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Federal Food, Drug, and Cosmetic Act

Index Federal Food, Drug, and Cosmetic Act

The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. [1]

294 relations: Adderall, Adolphus Hohensee, Adulterant, Adulterated food, Afamelanotide, Al Meyerhoff, Alternating electric field therapy, Amaranth (dye), Animal drug, Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013, Animal Drug Availability Act 1996, ApothéCure Inc., Approved Drug Products with Therapeutic Equivalence Evaluations, Aspergillus niger, Automated external defibrillator, B&O Supprettes, Beech-Nut, Biologics Control Act, Botanical drug, Buckman Co. v. Plaintiffs' Legal Committee, Bureau of Animal Industry, Caffeinated alcoholic drink, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Food Safety and Applied Nutrition, Chemical Diversion and Trafficking Act, Chlorpyrifos, Circle of Poison, Class I recall, Clinical trial, Clomifene, Consumer health laws, Consumer Movement, Consumer protection, Controlled Substances Act, Cosmeceutical, Cosmetics, Covered clinical study, Dalkon Shield, David Franklin (scientist), Delaney, Department of Homeland Security Appropriations Act, 2014, Designer Anabolic Steroid Control Act of 2014, Dextrobeam, Diet Coke Plus, Dietary supplement, Dietary Supplement Health and Education Act of 1994, Diethylene glycol, DoTerra, Draize test, ..., Drinking water, Drug Efficacy Study Implementation, Drug Price Competition and Patent Term Restoration Act, Drug Quality and Security Act, Drugs in the United States, Durham-Humphrey Amendment, Early history of food regulation in the United States, Eli Lilly & Co. v. Medtronic, Inc., Elixir sulfanilamide, Ellagic acid, Endocrine disruptor, Epigallocatechin gallate, Erythrosine, Ethics in pharmaceutical sales, Ethylene glycol poisoning, Eyelash perm, Fair Packaging and Labeling Act, False Claims Act, Family Smoking Prevention and Tobacco Control Act, FDA Food Safety Modernization Act, FDA v. Brown & Williamson Tobacco Corp., FDA warning letter, FDC, FDCA, Fecal microbiota transplant, Federal Insecticide, Fungicide, and Rodenticide Act, Federal Meat Inspection Act, Fisheries law, Flavor and Extract Manufacturers Association, Florence E. Wall, Fluorescein, Food additive, Food Additives Amendment of 1958, Food and Drug Administration, Food and Drug Administration Amendments Act of 2007, Food and Drug Administration Modernization Act of 1997, Food and Drug Administration Revitalization Act, Food and Drug Administration Safety and Innovation Act, Food coloring, Food defense, Food policy, Food Quality Protection Act, Forest Laboratories, Form FDA 483, Frances Oldham Kelsey, Franklin v. Parke-Davis, Frequency specific microcurrent, Generally recognized as safe, Generally recognized as safe and effective, Genetically modified food in North America, Genetically modified food in the United States, George P. 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Delaney, July 1960, June 1938, Kefauver Harris Amendment, Khat, Kinder Surprise, Kinsa, Krebiozen, Lanham Act, Liraglutide, List of acts of the 104th United States Congress, List of acts of the 105th United States Congress, List of acts of the 106th United States Congress, List of acts of the 107th United States Congress, List of acts of the 108th United States Congress, List of acts of the 109th United States Congress, List of acts of the 110th United States Congress, List of acts of the 111th United States Congress, List of acts of the 112th United States Congress, List of acts of the 113th United States Congress, List of acts of the 114th United States Congress, List of acts of the 115th United States Congress, List of bills in the 113th United States Congress, List of food additives, List of food contamination incidents, List of food labeling regulations, List of largest civil only pharmaceutical settlements, List of largest pharmaceutical settlements, List of legislation sponsored by Ron Paul, List of medicine contamination incidents, List of off-label promotion pharmaceutical settlements, List of United States federal environmental statutes, List of United States federal legislation, 1901–2001, List of United States Supreme Court cases by the Rehnquist Court, List of United States Supreme Court trademark case law, List of vaping bans in the United States, Louis Lasagna, M&M's, Mad in America, March 1960, Matthias Rath, Medical device, Medical Device Regulation Act, Medical food, MELA Sciences, Meprobamate, MERCI Retriever, Mercury regulation in the United States, Merrell Dow Pharmaceuticals Inc. v. Thompson, Microbial food cultures, Minimed Paradigm, MonaVie, Mutual Pharmaceutical Co. v. Bartlett, Nanotherapeutics (company), Nasal EPAP, National Drug Code, Natural foods, New chemical entity, New England Compounding Center meningitis outbreak, Nutrition Labeling and Education Act of 1990, Off-label use, Office of Criminal Investigations, Office of Global Regulatory Operations and Policy, Office of In Vitro Diagnostics and Radiological Health, Oragene, Organic movement, Organic statute (United States), Orphan Drug Act of 1983, Outline of clinical research, Over-the-counter drug, Oxygen bar, Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, Pascal Photocoagulator, Pasta, Peanut Corporation of America, Permanent makeup, Personal Sound Amplification Products, Pesticide regulation in the United States, Pharmaceutical fraud, Pharmaceutical industry, Pharmaceutical marketing, Picture archiving and communication system, PMA, POM Wonderful, POM Wonderful LLC v. Coca-Cola Co., Potassium bromate, Premarket tobacco application, Prescription drug, Prescription Drug Marketing Act, Prescription Drug User Fee Act, Project Bioshield Act, Protandim, Provision for Nutrition Labeling Under the Affordable Care Act, Psilocybin, Public Health Security and Bioterrorism Preparedness and Response Act, Public Law 114-214, Pure Food and Drug Act, Qui tam, Radiation Control for Health and Safety Act of 1968, Raw agricultural product, Regulation and prevalence of homeopathy, Regulation of electronic cigarettes, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Regulation of therapeutic goods, Regulatory affairs, Rexford Tugwell, Rintatolimod, Risk Evaluation and Mitigation Strategies, Robert Goldman (inventor), Rose, Royal S. Copeland, Rulemaking, S. E. Massengill Company, Saccharin, Safe Drinking Water Act, Safe Medical Device Amendments of 1990, ScanIP, Seafood mislabelling, Sparks (drink), Specialty drugs in the United States, Standards of identity for food, Stanozolol, Stop Online Piracy Act, Strengthening Public Health Emergency Response Act of 2015, Sulfanilamide, Sulfonamide (medicine), Sunscreen Innovation Act, Sunset Yellow FCF, Tartrazine, Theodore S. Weiss, Title 21 of the Code of Federal Regulations, Title 21 of the United States Code, Tobacco politics, Toftness device, Toxgnostics, Toxic Substances Control Act of 1976, Trade Sanction Reform and Export Enhancement Act, United Kingdom food labelling regulations, United States Department of Health and Human Services, United States v. 11 1/4 Dozen Packages of Articles Labeled in Part Mrs. Moffat's Shoo-Fly Powders for Drunkenness, United States v. Dotterweich, United States v. Park, United States v. Regenerative Sciences, LLC, Vagus nerve stimulation, Valdecoxib, Veterinary Feed Directive, Vinpocetine, Virus-Serum-Toxin Act, Vytex Natural Rubber Latex, Water fluoridation in the United States, Water quality law, Wilhelm Reich, Y1 (tobacco), Yellow, 100,000,000 Guinea Pigs, 2008 term United States Supreme Court opinions of Clarence Thomas, 2008 term United States Supreme Court opinions of John Paul Stevens, 2008 term United States Supreme Court opinions of Samuel Alito, 2008 term United States Supreme Court opinions of Stephen Breyer, 2012 term United States Supreme Court opinions of Samuel Alito, 2012 term United States Supreme Court opinions of Sonia Sotomayor, 2012 term United States Supreme Court opinions of Stephen Breyer, 2013 term United States Supreme Court opinions of Anthony Kennedy, 23andMe, 62 Cases of Jam v. United States, 75th United States Congress. Expand index (244 more) »

Adderall

Adderall, Adderall XR, and Mydayis are combination drugs containing four salts of the two enantiomers of amphetamine, a central nervous system (CNS) stimulant of the phenethylamine class.

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Adolphus Hohensee

Adolphus Hohensee (1901-1967) was a famous fraudulent nutritionist and quack from the twentieth century.

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Adulterant

An adulterant is a pejorative term for a substance found within other substances such as food, fuels or chemicals even though it is not allowed for legal or other reasons.

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Adulterated food

Adulteration is a legal term meaning that a food product fails to meet legal standards.

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Afamelanotide

Afamelanotide ((INN) (brand name Scenesse), also known as melanotan I (or melanotan-1), originally developed at the University of Arizona and now by Clinuvel Pharmaceuticals, is a synthetic peptide and analogue of the naturally occurring melanocortin peptide hormone α-melanocyte stimulating hormone (α-MSH) that has been shown to induce the production of darkening dermal pigmentation through melanogenesis and thereby subsequently reduce sun (UV) damage to UV light-exposed skin in preliminary research and human clinical trials. Its amino acid sequence is Ac-Ser-Tyr-Ser-Nle-Glu-His-D-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2, and it is additionally known as -α-MSH, which is sometimes abbreviated as NDP-MSH or NDP-α-MSH (especially in the scientific literature). Afamelanotide is the International Nonproprietary Name for the molecule α-MSH initially researched and developed as melanotan-1 and later, CUV1647 (by Clinuvel). A marketing trade name for one brand of afamelanotide was approved in 2010 by the European Medicines Agency (EMA) Name Review Group (NRG) and the agency's Committee for Medicinal Products for Human Use (CHMP) as Scenesse (pronounced "sen-esse"). On May 5, 2010 the Italian Medicines Agency (AIFA, or Agenzia Italiana del Farmaco) became the first governmental health organization ever (even before the drug received approval in Europe) to authorize afamelanotide as a medicine for therapeutic treatment of Italian citizens to reduce painful dermal photosensitivity stemming from the orphan disease erythropoietic protoporphyria (EPP). This approval allowed the drug to be immediately available for prescription in Italy and reimbursable under the country's national health system. Authorities in Switzerland have also allowed prescription of the drug for EPP with reimbursement approved by two unnamed insurers. Afamelanotide is currently being trialed in the form of a "grain of rice"-sized bioabsorbable subcutaneous implant as a potential therapeutic photoprotection-inducing agent for a series of light-related skin indications as well as a potential dermal repigmentation agent for vitiligo. Afamelanotide, as of October 24, 2014, has been approved by the EMA in Europe for the treatment of EPP. Clinuvel now intends to seek approval of afamelanotide in the United States. Unlicensed and untested powders sold as "melanotan" are found on the Internet and are reported to be used by tens of thousands of members of the general public for sunless tanning. Multiple regulatory bodies have warned consumers that the peptides may be unsafe and ineffective in usage, with one regulatory agency warning that consumers who purchase any product labeled "melanotan" risk buying a counterfeit drug. Clinuvel Pharmaceuticals, the developer of afamelanotide, and medical researchers have warned consumers that counterfeit products sold using the names "melanotan I and II", could "pose a hazard to public health". on counterfeit products. February 10, 2009. Clinuvel has stated publicly that products sold online as "melanotan" are not afamelanotide.

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Al Meyerhoff

Albert Henry "Al" Meyerhoff Jr. (September 20, 1947 – December 21, 2008) was an American labor, environmental and civil rights attorney.

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Alternating electric field therapy

Alternating electric field therapy, sometimes called tumor treating fields (TTF or TTFields), is a type of electromagnetic field therapy using low-intensity electrical fields to treat cancer.

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Amaranth (dye)

Amaranth, FD&C Red No.

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Animal drug

An animal drug (also veterinary drug) refers to a drug intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.

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Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013

The Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 is a bill that was introduced into the United States Senate during the 113th United States Congress.

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Animal Drug Availability Act 1996

The Animal Drug Availability Act 1996 (ADAA) is a United States federal law.

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ApothéCure Inc.

ApothéCure Inc. is a Dallas, Texas-based compounding pharmacy that specializes in custom compounded formulas and nutritional supplements for both patients and physicians.

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Approved Drug Products with Therapeutic Equivalence Evaluations

The Drug Price and Competition Act (Hatch-Waxman Act) requires FDA to publish Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

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Aspergillus niger

Aspergillus niger is a fungus and one of the most common species of the genus Aspergillus.

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Automated external defibrillator

An automated external defibrillator (AED) is a portable electronic device that automatically diagnoses the life-threatening cardiac arrhythmias of ventricular fibrillation and pulseless ventricular tachycardia, and is able to treat them through defibrillation, the application of electricity which stops the arrhythmia, allowing the heart to reestablish an effective rhythm.

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B&O Supprettes

B&O Supprettes is the brand name for a prescription medication containing powdered opium and belladonna alkaloids in a suppository form.

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Beech-Nut

Beech-Nut Nutrition Corporation is a baby food company that is owned by the Swiss branded consumer-goods firm Hero Group.

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Biologics Control Act

The Biologics Control Act of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of biological products such as vaccines in the United States.

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Botanical drug

A botanical drug is defined in the United States Federal Food, Drug, and Cosmetic Act as a botanical product that is marketed as diagnosing, mitigating, treating, or curing a disease; a botanical product in turn, is a finished, labeled product that contains ingredients from plants.

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Buckman Co. v. Plaintiffs' Legal Committee

Buckman Co.

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Bureau of Animal Industry

President Chester A. Arthur signed the Animal Industry Act on May 29, 1884 creating the Bureau of Animal Industry (BAI), an organization that was established under the United States Department of Agriculture.

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Caffeinated alcoholic drink

A caffeinated alcoholic drink, or caffeinated alcoholic beverage, is a drink that contains both alcohol (also known formally as ethanol) and caffeine.

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Center for Biologics Evaluation and Research

The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services.

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Center for Drug Evaluation and Research

The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.

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Center for Food Safety and Applied Nutrition

The Center for Food Safety and Applied Nutrition (CFSAN, pronounced sif'-san) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics.

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Chemical Diversion and Trafficking Act

The Chemical Diversion and Trafficking Act of 1988 was an amendment to the Controlled Substances Act to regulate precursor chemicals, essential chemicals, tableting machines, and encapsulating machines by imposing record keeping and import/export reporting requirements on transactions involving these materials.

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Chlorpyrifos

Chlorpyrifos (CPS), sold under many brandnames, is an organophosphate pesticide used to kill a number of pests including insects and worms.

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Circle of Poison

The Circle of Poison (COP) refers to the export of domestically banned pesticides for use on foods elsewhere, some of which returns by way of import.

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Class I recall

The United States Food and Drug Administration has published certain product recall policies applicable to consumer products.

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Clinical trial

Clinical trials are experiments or observations done in clinical research.

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Clomifene

Clomifene, also known as clomiphene, is a medication used to treat infertility in women who do not ovulate.

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Consumer health laws

Consumer Health Laws are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.

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Consumer Movement

The Consumer Movement is an effort to promote consumer protection through an organized social movement which is in many places led by consumer organizations.

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Consumer protection

In regulatory jurisdictions that provide for this (a list including most or all developed countries with free market economies) consumer protection is a group of laws and organizations designed to ensure the rights of consumers, as well as fair trade, competition, and accurate information in the marketplace.

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Controlled Substances Act

The Controlled Substances Act (CSA) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated.

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Cosmeceutical

Cosmeceuticals are cosmetic products with bioactive ingredients purported to have medical benefits.

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Cosmetics

Cosmetics are substances or products used to enhance or alter the appearance of the face or fragrance and texture of the body.

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Covered clinical study

In drug development, a covered clinical study refers to a clinical study, submitted to the Food and Drug Administration (FDA) as part of a marketing application (for example, as part of an NDA or 510(k)), about which the FDA may require disclosure of financial interest of the clinical investigator in the outcome of the study.

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Dalkon Shield

The Dalkon Shield was a contraceptive intrauterine device (IUD) developed by the Dalkon Corporation and marketed by the A.H. Robins Company.

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David Franklin (scientist)

David Franklin is an American microbiologist and former fellow of Harvard Medical School who while employed by Parke-Davis filed the 1996 whistleblower lawsuit exposing their illegal promotion of Neurontin (gabapentin) for off-label uses.

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Delaney

Delaney may refer to.

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Department of Homeland Security Appropriations Act, 2014

The Department of Homeland Security Appropriations Act, 2014 is an appropriations bill that was introduced into the United States House of Representatives during the 113th United States Congress.

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Designer Anabolic Steroid Control Act of 2014

The Designer Anabolic Steroid Control Act of 2014 is a bill that expanded the list of anabolic steroids regulated by the Drug Enforcement Administration (DEA) to include about two dozen new substances and established new crimes relating to false labeling of steroids.

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Dextrobeam

The Dextrobeam is a highly interactive console that enables collaborative examination of three-dimensional (3-D) medical imaging data for planning, discussing, or teaching neurosurgical approaches and strategies.

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Diet Coke Plus

Diet Coke Plus (also known as Coca Cola Light Plus) was a formulation of Diet Coke fortified with vitamins and minerals.

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Dietary supplement

A dietary supplement is a manufactured product intended to supplement the diet when taken by mouth as a pill, capsule, tablet, or liquid.

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Dietary Supplement Health and Education Act of 1994

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements.

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Diethylene glycol

Diethylene glycol (DEG) is an organic compound with the formula (HOCH2CH2)2O.

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DoTerra

doTerra (styled dōTERRA) is a multi-level marketing company based in Pleasant Grove, Utah that sells essential oils and other related products.

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Draize test

The Draize Test is an acute toxicity test devised in 1944 by Food and Drug Administration (FDA) toxicologists John H. Draize and Jacob M. Spines.

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Drinking water

Drinking water, also known as potable water, is water that is safe to drink or to use for food preparation.

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Drug Efficacy Study Implementation

Drug Efficacy Study Implementation (DESI) was a program begun by the Food and Drug Administration (FDA) in the 1960s after the requirement (in the Kefauver-Harris Drug Control Act) that all drugs be efficacious as well as safe, was made part of US law.

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Drug Price Competition and Patent Term Restoration Act

The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States.

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Drug Quality and Security Act

The Drug Quality and Security Act is a law that amended the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs.

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Drugs in the United States

In the United States, the Federal Food, Drug, and Cosmetic Act defined the word "drug" as an "article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" and those "(other than food) intended to affect the structure or any function of the body of man or other animals." Consistent with that definition, the U.S. separately defines narcotic drugs and controlled substances, which may include non-drugs, and explicitly excludes tobacco, caffeine and alcoholic beverages.

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Durham-Humphrey Amendment

The Durham-Humphrey Amendment explicitly defined two specific categories for medications, legend (prescription) and over-the-counter (OTC).

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Early history of food regulation in the United States

The history of early food regulation in the United States started with the 1906 Pure Food and Drug Act, when the United States federal government began to intervene in the food and drug businesses.

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Eli Lilly & Co. v. Medtronic, Inc.

Eli Lilly and Company v. Medtronic, Inc., 496 U.S. 661 (1990), is a United States Supreme Court case related to patent infringement in the Medical device industry.

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Elixir sulfanilamide

Elixir sulfanilamide was an improperly prepared sulfanilamide medicine that caused mass poisoning in the United States in 1937.

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Ellagic acid

Ellagic acid is a natural phenol antioxidant found in numerous fruits and vegetables.

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Endocrine disruptor

Endocrine disruptors are chemicals that can interfere with endocrine (or hormone) systems at certain doses.

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Epigallocatechin gallate

Epigallocatechin gallate (EGCG), also known as epigallocatechin-3-gallate, is the ester of epigallocatechin and gallic acid, and is a type of catechin.

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Erythrosine

Erythrosine, also known as Red No.

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Ethics in pharmaceutical sales

The ethics involved within pharmaceutical sales is built from the organizational ethics, which is a matter of system compliance, accountability and culture (Grace & Cohen, 2005).

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Ethylene glycol poisoning

Ethylene glycol poisoning is poisoning caused by drinking ethylene glycol.

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Eyelash perm

Eyelash permanent wave, or more commonly called an eyelash perm, and may also refer to permanent relaxer that straightens the hair is a cosmetics procedure performed only by licensed Cosmetologists to flip up eyelashes using hair perming technology.

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Fair Packaging and Labeling Act

The Fair Packaging and Labeling Act is a U.S. law that applies to labels on many consumer products.

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False Claims Act

The False Claims Act, also called the "Lincoln Law") is an American federal law that imposes liability on persons and companies (typically federal contractors) who defraud governmental programs. It is the federal Government's primary litigation tool in combating fraud against the Government. The law includes a qui tam provision that allows people who are not affiliated with the government, called "relators" under the law, to file actions on behalf of the government (informally called "whistleblowing" especially when the relator is employed by the organization accused in the suit). Persons filing under the Act stand to receive a portion (usually about 15–25 percent) of any recovered damages. As of 2012, over 70 percent of all federal Government FCA actions were initiated by whistleblowers. Claims under the law have typically involved health care, military, or other government spending programs, and dominate the list of largest pharmaceutical settlements. The government recovered $38.9 billion under the False Claims Act between 1987 and 2013 and of this amount, $27.2 billion or 70% was from qui tam cases brought by relators.

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Family Smoking Prevention and Tobacco Control Act

The Family Smoking Prevention and Tobacco Control Act, is a federal statute in the United States that was signed into law by President Barack Obama on June 22, 2009.

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FDA Food Safety Modernization Act

The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011.

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FDA v. Brown & Williamson Tobacco Corp.

FDA v. Brown & Williamson Tobacco Corp., is an important United States Supreme Court case in the development of American administrative law.

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FDA warning letter

An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.

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FDC

FDC may refer to.

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FDCA

FDCA may refer to.

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Fecal microbiota transplant

Fecal microbiota transplant (FMT), also known as a stool transplant, is the process of transplantation of fecal bacteria from a healthy individual into a recipient.

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Federal Insecticide, Fungicide, and Rodenticide Act

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is a United States federal law that set up the basic U.S. system of pesticide regulation to protect applicators, consumers, and the environment.

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Federal Meat Inspection Act

The Federal Meat Inspection Act of 1906 (FMIA) is an American law that makes it a crime to adulterate or misbrand meat and meat products being sold as food, and ensures that meat and meat products are slaughtered and processed under sanitary conditions.

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Fisheries law

Fisheries law is an emerging and specialized area of law.

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Flavor and Extract Manufacturers Association

The Flavor and Extract Manufacturers Association (FEMA) of the United States was founded in 1909 by several flavor firms in response to the passage of the Pure Food and Drug Act of 1906.

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Florence E. Wall

Florence Emeline Wall (1893 – October 2, 1988) was one of the first women to be recognized as a cosmetic chemist and the first woman to receive the medal of the Society of Cosmetic Chemists, in 1956.

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Fluorescein

Fluorescein is a manufactured organic compound and dye.

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Food additive

Food additives are substances added to food to preserve flavor or enhance its taste, appearance, or other qualities.

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Food Additives Amendment of 1958

The Food Additives Amendment of 1958 is a 1958 amendment to the United States' Food, Drugs, and Cosmetic Act of 1938.

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Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

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Food and Drug Administration Amendments Act of 2007

President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007.

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Food and Drug Administration Modernization Act of 1997

The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act.

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Food and Drug Administration Revitalization Act

The Food and Drug Administration Revitalization Act was introduced by the 101st Congress of the United States.

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Food and Drug Administration Safety and Innovation Act

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.

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Food coloring

Food coloring, or color additive, is any dye, pigment or substance that imparts color when it is added to food or drink.

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Food defense

Food defense is the protection of food products from intentional contamination or adulteration by biological, chemical, physical, or radiological agents introduced for the purpose of causing harm.

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Food policy

Food policy is the area of public policy concerning how food is produced, processed, distributed, and purchased.

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Food Quality Protection Act

The Food Quality Protection Act (FQPA), or H.R.1627, was passed unanimously by Congress in 1996 and was signed into law by President Bill Clinton on August 3, 1996.

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Forest Laboratories

Forest Laboratories was a company in the pharmaceutical industry incorporated in Delaware, with its principal office in New York City.

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Form FDA 483

The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec.

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Frances Oldham Kelsey

Frances Kathleen Oldham Kelsey, CM (July 24, 1914 – August 7, 2015) was a Canadian-American pharmacologist and physician.

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Franklin v. Parke-Davis

Franklin v. Parke-Davis is a lawsuit filed in 1996 against Parke-Davis, a division of Warner-Lambert Company, and eventually against Pfizer (which bought Warner-Lambert in 2000) under the qui tam provisions of the False Claims Act.

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Frequency specific microcurrent

Frequency specific microcurrent or frequency specific microcurrent therapy (FSMT) is the practice of introducing a mild electrical current into an area of damaged soft tissue.

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Generally recognized as safe

Generally recognized as safe (GRAS) is an American Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.

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Generally recognized as safe and effective

Generally recognized as safe and effective (abbreviated as GRASE, GRAS/E, or GRAS/GRAE) is designation for certain old drugs that do not require prior approval from the U.S. Food and Drug Administration in order to enter the United States marketplace because they are generally recognized as safe and effective by medical professionals.

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Genetically modified food in North America

Genetic engineering in North America is any genetic engineering activities in North America the United States, Canada, and Mexico do not require labeling of genetically modified foods.

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Genetically modified food in the United States

The United States is the largest grower of commercial crops that have been genetically engineered in the world, but not without domestic and international opposition.

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George P. Larrick

George P. Larrick (November 19, 1901August 11, 1968) was Commissioner of the U.S. Food and Drug Administration (FDA) from 19541965.

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Gilchrist & Soames

Gilchrist & Soames is a Plainfield, Indiana-based marketer of English-themed in-room toiletry hotel amenities.

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GlaxoSmithKline

GlaxoSmithKline plc (GSK) is a British pharmaceutical company headquartered in Brentford, London.

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GlobeStar Systems Inc.

GlobeStar Systems Inc.

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Glucomannan

Glucomannan is a water-soluble polysaccharide that is considered a dietary fiber.

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Glutamate flavoring

Glutamate flavoring is a generic name for flavor-enhancing compounds based on glutamic acid and its salts (glutamates).

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Good Housekeeping

Good Housekeeping is a women's magazine owned by the Hearst Corporation, featuring articles about women's interests, product testing by The Good Housekeeping Institute, recipes, diet, and health, as well as literary articles.

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Gould Amendment

The Gould Amendment sponsored by Rep.

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Growth hormone

Growth hormone (GH), also known as somatotropin (or as human growth hormone in its human form), is a peptide hormone that stimulates growth, cell reproduction, and cell regeneration in humans and other animals.

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Guidances for statistics in regulatory affairs

Guidances for statistics in regulatory affairs are applicable to the pharmaceutical industry and medical devices industry.

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Hazard

A hazard is an agent which has the potential to cause harm to a vulnerable target.

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Health and safety hazards of nanomaterials

The health and safety hazards of nanomaterials include the potential toxicity of various types of nanomaterials, as well as fire and dust explosion hazards.

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HGH controversies

Controversies regarding the use of human growth hormone (HGH) as treatment method have centered on the claims, products, and businesses related to the use of growth hormone as an anti-aging therapy.

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History of condoms

The history of condoms goes back at least several centuries, and perhaps beyond.

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History of the Food and Drug Administration

This article is about the history of the United States Food and Drug Administration.

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Homeopathy

Homeopathy or homœopathy is a system of alternative medicine developed in 1796 by Samuel Hahnemann, based on his doctrine of like cures like (similia similibus curentur), a claim that a substance that causes the symptoms of a disease in healthy people would cure similar symptoms in sick people.

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Horse slaughter

Horse slaughter is the practice of slaughtering horses to produce meat for consumption.

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Hubert Humphrey

Hubert Horatio Humphrey Jr. (May 27, 1911January 13, 1978) was an American politician who served as the 38th Vice President of the United States from 1965 to 1969.

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Human subject research legislation in the United States

Human subject research legislation in the United States can be traced to the early 20th century.

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Humanitarian Device Exemption

A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed without requiring evidence of effectiveness.

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Hyland's

Hyland's is a brand of homeopathic products sold in the United States and Canada.

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Impella

Impella is a family of medical devices used for temporary ventricular support device in people with depressed heart function.

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Indigo dye

Indigo dye is an organic compound with a distinctive blue color (see indigo).

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Industrial applications of nanotechnology

Nanotechnology is impacting the field of consumer goods, several products that incorporate nanomaterials are already in a variety of items; many of which people do not even realize contain nanoparticles, products with novel functions ranging from easy-to-clean to scratch-resistant.

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Infant formula

Infant formula, or baby formula, is a manufactured food designed and marketed for feeding to babies and infants under 12 months of age, usually prepared for bottle-feeding or cup-feeding from powder (mixed with water) or liquid (with or without additional water).

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International Numbering System for Food Additives

The International Numbering System for Food Additives (INS) is a European-based naming system for food additives, aimed at providing a short designation of what may be a lengthy actual name.

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Investigational device exemption

An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification submission to Food and Drug Administration (FDA).

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James J. Delaney

James Joseph Delaney (March 19, 1901 – May 24, 1987) was an American politician from New York.

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July 1960

The following events occurred in July 1960.

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June 1938

The following events occurred in June 1938.

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Kefauver Harris Amendment

The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.

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Khat

Khat or qat (Catha edulis, qat from القات) is a flowering plant native to the Horn of Africa and the Arabian Peninsula.

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Kinder Surprise

Kinder Surprise, also known as Kinder Egg or Kinder Surprise Egg, is a candy manufactured by the Italian company Ferrero SpA since 1974.

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Kinsa

Kinsa Inc. is a health technology company headquartered in San Francisco, California, United States.

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Krebiozen

Krebiozen (aka Carcalon, creatine, substance X, or drug X) is a disproven cancer treatment that is made available as an alternative cancer treatment.

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Lanham Act

The Lanham (Trademark) Act (codified at et seq.) is the primary federal trademark statute of law in the United States.

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Liraglutide

Liraglutide (NN2211) is a derivative of human incretin (metabolic hormone) glucagon-like peptide-1 (GLP-1) that is used as a long-acting glucagon-like peptide-1 receptor agonist, binding to the same receptors as does the endogenous metabolic hormone GLP-1 that stimulates insulin secretion.

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List of acts of the 104th United States Congress

The list of acts of the 104th United States Congress includes all Acts of Congress and ratified treaties by the 104th United States Congress, which lasted from January 3, 1995 to January 3, 1997.

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List of acts of the 105th United States Congress

The list of acts of the 105th United States Congress includes all Acts of Congress and ratified treaties by the 105th United States Congress, which lasted from January 3, 1997 to January 3, 1999.

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List of acts of the 106th United States Congress

The list of acts of the 106th United States Congress includes all Acts of Congress and ratified treaties by the 106th United States Congress, which lasted from January 3, 1999 to January 3, 2001.

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List of acts of the 107th United States Congress

The acts of the 107th United States Congress includes all Acts of Congress and ratified treaties by the 107th United States Congress, which lasted from January 3, 2001 to January 3, 2003 Acts include public and private laws, which are enacted after being passed by Congress and signed by the President, however if the President vetos a bill it can still be enacted by a two-thirds vote in both houses.

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List of acts of the 108th United States Congress

The acts of the 108th United States Congress includes all Acts of Congress and ratified treaties by the 108th United States Congress, which lasted from January 3, 2003 to January 3, 2005 Acts include public and private laws, which are enacted after being passed by Congress and signed by the President, however if the President vetos a bill it can still be enacted by a two-thirds vote in both houses.

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List of acts of the 109th United States Congress

The acts of the 109th United States Congress includes all Acts of Congress and ratified treaties by the 109th United States Congress, which lasted from January 3, 2005 to January 3, 2007 Acts include public and private laws, which are enacted after being passed by Congress and signed by the President, however if the President vetos a bill it can still be enacted by a two-thirds vote in both houses.

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List of acts of the 110th United States Congress

The 110th United States Congress enacted the following laws.

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List of acts of the 111th United States Congress

The acts of the 111th United States Congress include all laws enacted and treaties ratified by the 111th United States Congress, which lasted from January 3, 2009 to January 3, 2011.

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List of acts of the 112th United States Congress

The acts of the 112th United States Congress includes all Acts of Congress and ratified treaties by the 112th United States Congress, which lasts from January 3, 2011 to January 3, 2013.

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List of acts of the 113th United States Congress

The acts of the 113th United States Congress includes all Acts of Congress and ratified treaties by the 113th United States Congress, which lasted from January 3, 2013 to January 3, 2015.

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List of acts of the 114th United States Congress

The list of acts of the 114th United States Congress includes all Acts of Congress and ratified treaties by the 114th United States Congress, which began on January 3, 2015, and lasted until January 3, 2017.

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List of acts of the 115th United States Congress

The list of acts of the 115th United States Congress includes all Acts of Congress and ratified treaties by the 115th United States Congress, which began on January 3, 2017, and will last until January 3, 2019.

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List of bills in the 113th United States Congress

The bills of the 113th United States Congress list includes proposed federal laws that were introduced in the 113th United States Congress.

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List of food additives

;Acids: Food acids are added to make flavors "sharper", and also act as preservatives and antioxidants.

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List of food contamination incidents

Food may be accidentally or deliberately contaminated by microbiological, chemical or physical hazards.

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List of food labeling regulations

The packaging and labeling of food is subject to regulation in most regions/jurisdictions, both to prevent false advertising and to promote food safety.

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List of largest civil only pharmaceutical settlements

The following is a list of the 21 largest civil settlements, reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2017, ordered by the size of the total civil settlement.

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List of largest pharmaceutical settlements

The following is a list of the 20 largest settlements reached between the United States Department of Justice and pharmaceutical companies from 1991 to 2012, ordered by the size of the total settlement.

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List of legislation sponsored by Ron Paul

Ron Paul, a Republican United States Congressman from Lake Jackson, Texas, has sponsored many bills in the United States House of Representatives, such as those that would abolish the income tax or the Federal Reserve.

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List of medicine contamination incidents

The following list encompasses notable medicine contamination and adulteration incidents.

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List of off-label promotion pharmaceutical settlements

The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs.

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List of United States federal environmental statutes

The laws listed below meet the following criteria: (1) they were passed by the United States Congress, and (2) pertain to (a) the regulation of the interaction of humans and the natural environment, or (b) the conservation and/or management of natural or historic resources.

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List of United States federal legislation, 1901–2001

This is a chronological, but incomplete, list of United States federal legislation passed by the 57th through 106th United States Congresses, between 1901 and 2001.

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List of United States Supreme Court cases by the Rehnquist Court

This is a partial chronological list of cases decided by the United States Supreme Court during the Rehnquist Court, the tenure of Chief Justice William Rehnquist from September 26, 1986 through September 3, 2005.

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List of United States Supreme Court trademark case law

This is an incomplete list of Supreme Court of the United States cases in the area of trademark law.

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List of vaping bans in the United States

The following is a list of vaping bans in the United States.

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Louis Lasagna

Louis Lasagna (February 22, 1923 – August 6, 2003) was an American physician and professor of medicine, known for his revision of the Hippocratic Oath.

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M&M's

M&M's are "colorful button-shaped chocolates", each of which has the letter "m" printed in lower case on one side, surrounding a filling which varies depending upon the variety of M&M's.

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Mad in America

Mad in America: Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill is a 2002 book by medical journalist Robert Whitaker, in which the author examines and questions the efficacy, safety, and ethics of past psychiatric interventions for severe mental illnesses, particularly antipsychotics.

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March 1960

The following events occurred in March 1960.

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Matthias Rath

Matthias Rath (born 1955 in Stuttgart, Germany) is a controversial doctor, businessman, and vitamin salesman.

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Medical device

A medical device is any apparatus, appliance, software, material, or other article—whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application—intended by the manufacturer to be used for human beings for the purpose of.

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Medical Device Regulation Act

The Medical Device Regulation Act or Medical Device Amendments of 1976 was introduced by the 94th Congress of the United States.

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Medical food

Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone.

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MELA Sciences

MELA Sciences is an American medical device company focused on the design, development and commercialization of non-invasive tools to provide additional information to dermatologists during melanoma skin examinations.

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Meprobamate

Meprobamate — marketed as Miltown by Wallace Laboratories and Equanil by Wyeth, among others — is a carbamate derivative used as an anxiolytic drug.

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MERCI Retriever

The MERCI Retriever is a medical device designed to treat Ischemic Strokes.

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Mercury regulation in the United States

Mercury regulation in the United States is a set of laws and regulations limiting the maximum concentrations of mercury (Hg) that is permitted in air, water, soil, food and drugs.

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Merrell Dow Pharmaceuticals Inc. v. Thompson

Merrell Dow Pharmaceuticals Inc.

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Microbial food cultures

Microbial food cultures are live bacteria, yeasts or moulds used in food production.

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Minimed Paradigm

MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus.

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MonaVie

MonaVie is a defunct, American multi-level marketing company that manufactured and distributed products made from blended fruit juice concentrates, powders, and purées.

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Mutual Pharmaceutical Co. v. Bartlett

Mutual Pharmaceutical Co.

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Nanotherapeutics (company)

Nanotherapeutics, Inc. is a private, American biopharmaceutical company headquartered in Alachua, Florida.

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Nasal EPAP

Nasal expiratory positive airway pressure (Nasal EPAP) is a treatment for obstructive sleep apnea (OSA) and snoring.

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National Drug Code

The National Drug Code (NDC) is a unique product identifier used in the United States for drugs intended for human use.

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Natural foods

Natural foods and all natural foods are widely used terms in food labeling and marketing with a variety of definitions, most of which are vague.

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New chemical entity

A new chemical entity (NCE) is, according to the U.S. Food and Drug Administration, a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.

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New England Compounding Center meningitis outbreak

A New England Compounding Center meningitis outbreak that began in September 2012 sickened over 800 individuals and resulted in the deaths of 76.

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Nutrition Labeling and Education Act of 1990

The Nutrition Labeling and Education Act (NLEA) (Public Law 101-535) is a 1990 United States Federal law.

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Off-label use

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration.

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Office of Criminal Investigations

The Office of Criminal Investigations (OCI) was established to provide the US Food and Drug Administration (FDA) with a specific Office to conduct and coordinate Criminal investigations.

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Office of Global Regulatory Operations and Policy

The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products which may have potentially harmful side effects for the consumer.

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Office of In Vitro Diagnostics and Radiological Health

The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.

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Oragene

Oragene is the trade name for DNA Genotek’s non-invasive DNA self-collection kit.

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Organic movement

The organic movement broadly refers to the organizations and individuals involved worldwide in the promotion of organic farming and other organic products.

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Organic statute (United States)

In United States administrative law, an organic statute is a statute enacted by Congress that creates an administrative agency and defines its authorities and responsibilities.

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Orphan Drug Act of 1983

The Orphan Drug Act of 1983 is a law passed in the United States to facilitate development of orphan drugs — drugs for rare diseases such as Huntington's Disease, myoclonus, ALS, Tourette syndrome and muscular dystrophy which affect small numbers of individuals residing in the United States.

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Outline of clinical research

The following outline is provided as an overview of and topical guide to clinical research: Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans.

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Over-the-counter drug

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a prescription from a healthcare professional, as opposed to prescription drugs, which may be sold only to consumers possessing a valid prescription.

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Oxygen bar

An oxygen bar is an establishment, or part of one, that sells oxygen for recreational use.

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Pandemic and All-Hazards Preparedness Reauthorization Act of 2013

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 is a law enacted by the 113th United States Congress.

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Pascal Photocoagulator

The PASCAL Photocoagulator is an integrated semi-automatic pattern scan laser photocoagulation system designed to treat ocular diseases using a single shot or predetermined pattern array.

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Pasta

Pasta is a staple food of traditional Italian cuisine, with the first reference dating to 1154 in Sicily.

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Peanut Corporation of America

Peanut Corporation of America (PCA) was a peanut-processing business with headquarters in Lynchburg, Virginia, plants in other southern states, and distribution across the United States, now defunct as a result of one of the most massive and lethal food-borne contamination events in U.S. history.

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Permanent makeup

Permanent makeup is a cosmetic technique which employs tattoos (permanent pigmentation of the dermis) as a means of producing designs that resemble makeup, such as eyelining and other permanent enhancing colors to the skin of the face, lips, and eyelids.

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Personal Sound Amplification Products

Personal Sound Amplification Products, also known as "Personal Sound Amplification Devices," or by the acronym PSAP, are defined by the U.S. Food and Drug Administration as wearable electronic products that are intended to amplify sounds for people who are not d/Deaf or Hard of Hearing.

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Pesticide regulation in the United States

Pesticide regulation in the United States is primarily a responsibility of the Environmental Protection Agency.

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Pharmaceutical fraud

Pharmaceutical fraud involves activities that result in false claims to insurers or programs such as Medicare in the United States or equivalent state programs for financial gain to a pharmaceutical company.

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Pharmaceutical industry

The pharmaceutical industry (or medicine industry) is the commercial industry that discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as different types of medicine and medications.

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Pharmaceutical marketing

Pharmaceutical marketing, sometimes called medico-marketing or pharma marketing in some countries, is the business of advertising or otherwise promoting the sale of pharmaceutical drugs.

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Picture archiving and communication system

A picture archiving and communication system (PACS) is a medical imaging technology which provides economical storage and convenient access to images from multiple modalities (source machine types).

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PMA

PMA may mean.

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POM Wonderful

POM Wonderful, LLC is a private company which sells an eponymous brand of beverages and fruit extracts.

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POM Wonderful LLC v. Coca-Cola Co.

POM Wonderful LLC v. Coca-Cola Co., (2014), was United States Supreme Court case that held that a statutory private right of action under the Lanham Act is not precluded by regulatory provisions of the Food, Drug, and Cosmetic Act.

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Potassium bromate

Potassium bromate (KBrO3), is a bromate of potassium and takes the form of white crystals or powder.

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Premarket tobacco application

A premarket tobacco application (PMTA) is an application that must be reviewed and approved by the Food and Drug Administration before a new tobacco product can be legally marketed in the United States.

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Prescription drug

A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed.

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Prescription Drug Marketing Act

The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.

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Prescription Drug User Fee Act

The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.

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Project Bioshield Act

The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack.

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Protandim

Protandim is a herbal dietary supplement marketed with unsupported claims that it can treat a number of medical conditions.

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Provision for Nutrition Labeling Under the Affordable Care Act

Section 4205 of the Patient Protection and Affordable Care Act (ACA) requires that standard menu items at qualifying chain restaurants and vending machines have proper nutrition labeling.

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Psilocybin

Psilocybin is a naturally occurring psychedelic prodrug compound produced by more than 200 species of mushrooms, collectively known as psilocybin mushrooms.

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Public Health Security and Bioterrorism Preparedness and Response Act

Signed into effect on 12 June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act, (PHSBPRA) was signed by the President, the Department of Health and Human Services (DHHS) and the U.S. Department of Agriculture (USDA).

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Public Law 114-214

Public Law 114-216 is the federal law of the United States that regulates GMO food labeling.

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Pure Food and Drug Act

The Pure Food and Drug Act of 1906 was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration.

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Qui tam

In common law, a writ of qui tam is a writ whereby a private individual who assists a prosecution can receive all or part of any penalty imposed.

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Radiation Control for Health and Safety Act of 1968

Radiation Control for Health and Safety Act of 1968 was an amendment to the Public Health Service Act mandating performance standards for electronic products suspectible of electromagnetic radiation or radiation emissions.

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Raw agricultural product

Raw agricultural product, as defined by the United States Federal Food, Drug, and Cosmetic Act, is “any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in the unpeeled natural form prior to marketing.” The nonregulatory definition generally means any agricultural commodity that has undergone little or no processing.

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Regulation and prevalence of homeopathy

Homeopathy is fairly common in some countries while being uncommon in others.

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Regulation of electronic cigarettes

Regulation of electronic cigarettes varies across countries and states, ranging from no regulation to banning them entirely.

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Regulation of food and dietary supplements by the U.S. Food and Drug Administration

The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA").

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Regulation of therapeutic goods

The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction.

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Regulatory affairs

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc.

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Rexford Tugwell

Rexford Guy Tugwell (July 10, 1891 – July 21, 1979) was an economist who became part of Franklin D. Roosevelt's first "Brain Trust," a group of Columbia University academics who helped develop policy recommendations leading up to Roosevelt's New Deal.

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Rintatolimod

Rintatolimod, sold under the tradename Ampligen, is a medication intended for treatment of chronic fatigue syndrome (CFS).

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Risk Evaluation and Mitigation Strategies

Risk Evaluation and Mitigation Strategies is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects.

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Robert Goldman (inventor)

Robert Goldman (born 1959 in Rochester, New York) is an American inventor responsible for pioneering technology in digital media as well as cancer treatment.

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Rose

A rose is a woody perennial flowering plant of the genus Rosa, in the family Rosaceae, or the flower it bears.

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Royal S. Copeland

Royal Samuel Copeland (November 7, 1868June 17, 1938), a United States Senator from New York from 1923 until 1938, was an academic, homeopathic physician, and politician.

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Rulemaking

In administrative law, rule-making is the process that executive and independent agencies use to create, or promulgate, regulations.

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S. E. Massengill Company

S.

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Saccharin

Sodium saccharin (benzoic sulfimide) is an artificial sweetener with effectively no food energy that is about 300–400 times as sweet as sucrose but has a bitter or metallic aftertaste, especially at high concentrations.

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Safe Drinking Water Act

The Safe Drinking Water Act (SDWA) is the principal federal law in the United States intended to ensure safe drinking water for the public.

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Safe Medical Device Amendments of 1990

Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act.

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ScanIP

ScanIP is a 3D image processing and model generation app developed by Synopsys Inc. to visualise, analyse, quantify, segment and export 3D image data from magnetic resonance imaging (MRI), computed tomography (CT), microtomography and other modalities for computer-aided design (CAD), finite element analysis (FEA), computational fluid dynamics (CFD), and 3D printing.

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Seafood mislabelling

Seafood species can be mislabelled in misleading ways.

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Sparks (drink)

Sparks is an alcoholic beverage that debuted in the US market in 2002.

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Specialty drugs in the United States

Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals that are classified as high-cost, high complexity and/or high touch.

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Standards of identity for food

Standards of identity for food are mandatory requirements that are set by a governing body to determine what a food product must contain to be marketed under a certain name in allowable commerce.

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Stanozolol

Stanozolol, sold under many brand names, is an androgen and anabolic steroid (AAS) medication which was derived from dihydrotestosterone (DHT).

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Stop Online Piracy Act

The Stop Online Piracy Act (SOPA) was a controversial United States bill introduced by U.S. Representative Lamar S. Smith (R-TX) to expand the ability of U.S. law enforcement to combat online copyright infringement and online trafficking in counterfeit goods.

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Strengthening Public Health Emergency Response Act of 2015

The Strengthening Public Health Emergency Response Act of 2015, H.R. 3299, is a bill introduced in the U.S. House of Representatives that would streamline government decisions and provide incentives for vaccines and treatment of dangerous pathogens and diseases.

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Sulfanilamide

Sulfanilamide (also spelled sulphanilamide) is a sulfonamide antibacterial.

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Sulfonamide (medicine)

Sulfonamide (also called sulphonamide, sulfa drugs or sulpha drugs) is the basis of several groups of drugs.

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Sunscreen Innovation Act

The Sunscreen Innovation Act is a 2014 law that amended the Federal Food, Drug, and Cosmetic Act to establish an expedited process for the review and approval of over-the-counter (OTC) sunscreens.

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Sunset Yellow FCF

Sunset Yellow FCF (also known as Orange Yellow S, or C.I. 15985) is a petroleum-derived orange azo dye with a pH dependent maximum absorption at about 480 nm at pH 1 and 443 nm at pH 13 with a shoulder at 500 nm.

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Tartrazine

Tartrazine is a synthetic lemon yellow azo dye primarily used as a food coloring.

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Theodore S. Weiss

Theodore S. "Ted" Weiss (September 17, 1927 – September 14, 1992) was a Democratic member of the United States House of Representatives from New York serving from 1977 until his death from heart failure in New York City in 1992.

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Title 21 of the Code of Federal Regulations

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

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Title 21 of the United States Code

Title 21 of the United States Code governs Food and Drugs in the United States Code (U.S.C.).

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Tobacco politics

Tobacco politics refers to the politics surrounding the use and distribution of tobacco.

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Toftness device

The Toftness Radiation Detector is an instrument used by some chiropractors.

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Toxgnostics

Toxgnostics is part of Personalized medicine as it describes the guiding principles for the discovery of pharmacogenomic biomarker tests, also referred to as companion diagnostic tests, which identify if an individual patient is likely to suffer severe drug toxicity from treatment with a specific therapeutic agent.

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Toxic Substances Control Act of 1976

The Toxic Substances Control Act (TSCA) is a United States law, passed by the United States Congress in 1976 and administered by the United States Environmental Protection Agency, that regulates the introduction of new or already existing chemicals.

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Trade Sanction Reform and Export Enhancement Act

The Trade Sanction Reform and Export Enhancement Act (Title IX) was enacted by the United States Congress and signed by President Bill Clinton in 2000 (www.fas.usda.gov).

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United Kingdom food labelling regulations

The law in the UK on food labelling is multifaceted and is spread over many reforms and parliamentary acts, making the subject complex.

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United States Department of Health and Human Services

The United States Department of Health and Human Services (HHS), also known as the Health Department, is a cabinet-level department of the U.S. federal government with the goal of protecting the health of all Americans and providing essential human services.

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United States v. 11 1/4 Dozen Packages of Articles Labeled in Part Mrs. Moffat's Shoo-Fly Powders for Drunkenness

United States v. 11 1/4 Dozen Packages of Articles Labeled in Part Mrs.

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United States v. Dotterweich

United States v. Dotterweich,, was a United States Supreme Court case in which the Court upheld strict, vicarious liability for the president of a company convicted of a public welfare offense.

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United States v. Park

United States v. Park, 421 U.S. 658 (1975), was a case in which the Supreme Court of the United States held that the Food and Drug Administration (FDA) could pierce the corporate veil.

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United States v. Regenerative Sciences, LLC

United States of America v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014), was a decision in the United States Court of Appeals for the District of Columbia Circuit filed on February 4, 2014 concerning more than minimally manipulated cell therapies and whether they are considered part of medical practice or a drug, the latter subjecting it to regulation under the Food and Drug Administration (FDA).

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Vagus nerve stimulation

Vagus nerve stimulation or vagal nerve stimulation (VNS) is a medical treatment that involves delivering electrical impulses to the vagus nerve.

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Valdecoxib

Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms.

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Veterinary Feed Directive

In United States agricultural policy, a Veterinary Feed Directive (VFD) is a written statement that authorizes the owner or caretaker of animals to obtain and use animal feed containing VFD drugs to treat their animals in accordance with the FDA-approved directions for use.

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Vinpocetine

Vinpocetine (brand names: Cavinton, Intelectol; chemical name: ethyl apovincaminate) is a synthetic derivative of the vinca alkaloid vincamine (sometimes described as "a synthetic ethyl ester of apovincamine"), an extract from the lesser periwinkle plant.

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Virus-Serum-Toxin Act

The Virus-Serum-Toxin Act or VSTA (P.L. 430 of 1913, as amended; 21 U.S.C. 151-158) was United States Federal legislation designed to protect farmers and livestock raisers by regulating the quality of vaccines and point-of-care diagnostics for animals.

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Vytex Natural Rubber Latex

Vytex Natural Rubber Latex (NRL) is a brand of natural rubber latex produced and marketed by Vystar Corporation.

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Water fluoridation in the United States

As with some other countries, water fluoridation in the United States is a contentious issue.

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Water quality law

Water quality laws govern the release of pollutants into water resources, including surface water, ground water, and stored drinking water.

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Wilhelm Reich

Wilhelm Reich (24 March 1897 – 3 November 1957) was an Austrian doctor of medicine and psychoanalyst, a member of the second generation of analysts after Sigmund Freud.

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Y1 (tobacco)

Y1 is a strain of tobacco that was cross-bred by Brown & Williamson to obtain an unusually high nicotine content.

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Yellow

Yellow is the color between orange and green on the spectrum of visible light.

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100,000,000 Guinea Pigs

100,000,000 Guinea Pigs: Dangers in Everyday Foods, Drugs, and Cosmetics is a book written by Arthur Kallet and F.J. Schlink first released in 1933 by the Vanguard Press and manufactured in the United States of America.

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2008 term United States Supreme Court opinions of Clarence Thomas

No description.

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2008 term United States Supreme Court opinions of John Paul Stevens

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2008 term United States Supreme Court opinions of Samuel Alito

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2008 term United States Supreme Court opinions of Stephen Breyer

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2012 term United States Supreme Court opinions of Samuel Alito

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2012 term United States Supreme Court opinions of Sonia Sotomayor

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2012 term United States Supreme Court opinions of Stephen Breyer

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2013 term United States Supreme Court opinions of Anthony Kennedy

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23andMe

23andMe is a privately held personal genomics and biotechnology company based in Mountain View, California.

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62 Cases of Jam v. United States

62 Cases of Jam v. United States,, was a United States Supreme Court case in which the Court held that "imitation jam," so labeled, was not a "misbranded" product under § 403 of the Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. § 343, even though it did not meet federal regulations for being fruit jam.

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75th United States Congress

The Seventy-fifth United States Congress was a meeting of the legislative branch of the United States federal government, composed of the United States Senate and the United States House of Representatives.

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Redirects here:

510(k), 510K, 510k, FD&C, FD&C Act, FDA (510k) filing, FFDCA, Federal Food Drug and Cosmetic Act, Federal Food, Drug and Cosmetic Act, Federal Food, Drugs, and Cosmetics Act, Food, Drug and Cosmetic Act, Food, Drug, and Cosmetic Act, PMA (FDA), Pre-market approval, Premarket Notification, Premarket approval, Premarket notification.

References

[1] https://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act

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