214 relations: Abbreviated New Drug Application, Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, ACT UP, Adverse drug reaction, Adverse effect, Adverse event, Advice and consent, Airport security, Amygdalin, Animal feed, Aspirin, Assisted reproductive technology, Autoimmunity, Bacteria, Barack Obama, Bevacizumab, Biologics Control Act, Biopharmaceutical, Biostatistics, Blood transfusion, Bovine spongiform encephalopathy, Brand, Cancer, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Food Safety and Applied Nutrition, Center for Tobacco Products, Center for Veterinary Medicine, Central Drugs Standard Control Organization, Cleveland Clinic, Clinical trial, Commissioner of Food and Drugs, Competition law, Controlled Substances Act, Cosmeceutical, Criticism of the Food and Drug Administration, Danish Medicines Agency, David R. Henderson, Diabetes mellitus, Diana Zuckerman, Dietary supplement, Diphtheria, Drink, Drug Efficacy Study Implementation, Drug Enforcement Administration, Drug Price Competition and Patent Term Restoration Act, Duke University, Durham-Humphrey Amendment, Ebola virus disease, Electromagnetic radiation, ..., Elixir sulfanilamide, Endo International plc, Enzyme replacement therapy, European Medicines Agency, Excipient, Expanded access, Family Smoking Prevention and Tobacco Control Act, Fast track (FDA), FDA Food Safety Modernization Act, Federal Bureau of Investigation, Federal Commission for the Protection against Sanitary Risk, Federal Food, Drug, and Cosmetic Act, Federal government of the United States, Federal Institute for Drugs and Medical Devices, Federal judiciary of the United States, Federal Register, Federal Trade Commission, First Amendment to the United States Constitution, Floyd Abrams, Food additive, Food administration, Food and Drug Administration Amendments Act of 2007, Food and Drug Administration Modernization Act of 1997, Food and Drug Administration Safety and Innovation Act, Food industry, Food safety, Food Safety and Standards Authority of India, Form FDA 483, Frances Oldham Kelsey, Franklin D. Roosevelt, Gaucher's disease, George W. Bush, Harvey Washington Wiley, Headquarters, Health Canada, Health care prices in the United States, Health informatics, Health insurance, Hirudo medicinalis, HIV, HIV/AIDS, Ibuprofen, Imiglucerase, Imperial Brands, Indoor tanning, Informed consent, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Interpol, Inverse benefit law, Investigational device exemption, IPLEDGE program, Isotretinoin, Jim (horse), Kefauver Harris Amendment, Laboratory, Laser, Legal liability, Libertarianism, Liberty Fund, List of federal agencies in the United States, Lorillard Tobacco Company, Maggot therapy, Marketed Health Products Directorate, Mascara, Medical cannabis, Medical device, Medication, Medicines and Healthcare products Regulatory Agency, MedWatch, Mercatus Center, Microwave oven, Ministry of Health, Labour and Welfare, Mobile app, Mobile phone, Monopoly, Muckraker, Mylan, Myocardial infarction, National Academy of Medicine, National Center for Health Research, National Center for Toxicological Research, National Institutes of Health, National Sanitary Surveillance Agency, Naval Ordnance Laboratory, Neglected tropical diseases, Neurostimulation, New Drug Application, Nonsteroidal anti-inflammatory drug, Off-label use, Office of Criminal Investigations, Office of Global Regulatory Operations and Policy, Office of In Vitro Diagnostics and Radiological Health, OpenFDA, Opioid, Over-the-counter drug, Oxymorphone, Packaging and labeling, Pasteurization, Pediatrics, Pet, Pharmaceutical industry, Pharmaceuticals and Medical Devices Agency, Pharmacokinetics, Physician, Polytetrafluoroethylene, Postmarketing surveillance, Prescription drug, Prescription Drug User Fee Act, President of the United States, Prime Minister of Canada, Priority review, Progressive Era, Protein, Public health, Public Health Service Act, Puerto Rico, Pure Food and Drug Act, R. J. Reynolds, Racket (crime), Radioactive decay, Regulation, Robert C. Randall, Rofecoxib, Santa Fe Natural Tobacco Company, Science policy of the United States, Scott Gottlieb, Silver Spring, Maryland, Sperm donation, Stephen Harper, Supreme Court of the United States, Television, Thalidomide, The Wall Street Journal, Theodore Roosevelt, Title 18 of the United States Code, Title 21 of the United States Code, Tobacco, Tobacco products, Toothbrush, Triamterene, Tuberculosis, U.S. Consumer Product Safety Commission, U.S. Customs and Border Protection, U.S. Securities and Exchange Commission, U.S. state, United States, United States Assistant Attorney General, United States Congress, United States Department of Agriculture, United States Department of Health and Human Services, United States federal executive departments, United States House Committee on Energy and Commerce, United States Secretary of Health and Human Services, United States Senate, United States Virgin Islands, Upton Sinclair, Vaccine, Vaccine Act of 1813, Veterinary medicine, Washington metropolitan area, Washington, D.C., West African Ebola virus epidemic, White Oak, Maryland, ZMapp. Expand index (164 more) » « Shrink index
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.
Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), cert denied, 552 U.S. 1159 (2008) was resolved in early 2008 when the Supreme Court of the United States declined to hear the appeal.
AIDS Coalition to Unleash Power (ACT UP) is an international direct action advocacy group working to impact the lives of people with AIDS (PWAs) and the AIDS pandemic to bring about legislation, medical research and treatment and policies to ultimately bring an end to the disease by mitigating loss of health and lives.
An adverse drug reaction (ADR) is an injury caused by taking a medication.
In medicine, an adverse effect is an undesired harmful effect resulting from a medication or other intervention such as surgery.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Advice and consent is an English phrase frequently used in enacting formulae of bills and in other legal or constitutional contexts.
Airport security refers to the techniques and methods used in an attempt to protect passengers, staff and planes which use the airports from accidental/malicious harm, crime and other threats.
Amygdalin (from Ancient Greek: ἀμυγδαλή amygdálē "almond") is a naturally occurring chemical compound, famous for falsely being promoted as a cancer cure.
Animal feed is food given to domestic animals in the course of animal husbandry.
Aspirin, also known as acetylsalicylic acid (ASA), is a medication used to treat pain, fever, or inflammation.
Assisted reproductive technology (ART) is the technology used to achieve pregnancy in procedures such as fertility medication, in vitro fertilization and surrogacy.
Autoimmunity is the system of immune responses of an organism against its own healthy cells and tissues.
Bacteria (common noun bacteria, singular bacterium) is a type of biological cell.
Barack Hussein Obama II (born August 4, 1961) is an American politician who served as the 44th President of the United States from January 20, 2009, to January 20, 2017.
Bevacizumab, sold under the trade name Avastin, is medication used to treat a number of types of cancers and a specific eye disease.
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.
A biopharmaceutical, also known as a biologic(al) medical product, biological, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources.
Biostatistics is the application of statistics to a wide range of topics in biology.
Blood transfusion is generally the process of receiving blood or blood products into one's circulation intravenously.
Bovine spongiform encephalopathy (BSE), commonly known as mad cow disease, is a transmissible spongiform encephalopathy and fatal neurodegenerative disease in cattle that may be passed to humans who have eaten infected flesh.
A brand is a name, term, design, symbol, or other feature that distinguishes an organization or product from its rivals in the eyes of the customer.
Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body.
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.
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.
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.
The Center for Tobacco Products (CTP) was established by the United States Food and Drug Administration as a result of the Family Smoking Prevention and Tobacco Control Act signed by President Obama in June 2009.
The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals.
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.
The Cleveland Clinic is a multispecialty academic hospital in Cleveland, Ohio, that is owned and operated by the Cleveland Clinic Foundation, an Ohio nonprofit corporation established in 1921.
Clinical trials are experiments or observations done in clinical research.
The Commissioner of Food and Drugs is the head of the Food and Drug Administration (FDA), an agency of the United States Department of Health and Human Services.
Competition law is a law that promotes or seeks to maintain market competition by regulating anti-competitive conduct by companies.
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.
Cosmeceuticals are cosmetic products with bioactive ingredients purported to have medical benefits.
Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation.
The Danish Medicines Agency (Lægemiddelstyrelsen) is an agency under the Danish Ministry of Health and Prevention.
David R. Henderson (born November 21, 1950) is a Canadian-born American economist and author who moved to the United States in 1972 and became a U.S. citizen in 1986, serving on President Ronald Reagan’s Council of Economic Advisers from 1982 to 1984.
Diabetes mellitus (DM), commonly referred to as diabetes, is a group of metabolic disorders in which there are high blood sugar levels over a prolonged period.
Diana M. Zuckerman (born 16 June 1950) is an American health policy analyst who focuses on the implications of policies for public health and patients’ health.
A dietary supplement is a manufactured product intended to supplement the diet when taken by mouth as a pill, capsule, tablet, or liquid.
Diphtheria is an infection caused by the bacterium Corynebacterium diphtheriae.
A drink or beverage is a liquid intended for human consumption.
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.
The Drug Enforcement Administration (DEA) is a United States federal law enforcement agency under the United States Department of Justice, tasked with combating drug smuggling and use within the United States.
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.
Duke University is a private, non-profit, research university located in Durham, North Carolina.
The Durham-Humphrey Amendment explicitly defined two specific categories for medications, legend (prescription) and over-the-counter (OTC).
Ebola virus disease (EVD), also known as Ebola hemorrhagic fever (EHF) or simply Ebola, is a viral hemorrhagic fever of humans and other primates caused by ebolaviruses.
In physics, electromagnetic radiation (EM radiation or EMR) refers to the waves (or their quanta, photons) of the electromagnetic field, propagating (radiating) through space-time, carrying electromagnetic radiant energy.
Elixir sulfanilamide was an improperly prepared sulfanilamide medicine that caused mass poisoning in the United States in 1937.
Endo International plc is a generics and specialty branded pharmaceutical company.
Enzyme replacement therapy (ERT) is a medical treatment which replaces an enzyme that is deficient or absent in the body.
The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products.
An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred to as "bulking agents", "fillers", or "diluents"), or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility.
Expanded access is the use of an unapproved drug or medical device under specials forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
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.
Fast Track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need.
The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011.
The Federal Bureau of Investigation (FBI), formerly the Bureau of Investigation (BOI), is the domestic intelligence and security service of the United States, and its principal federal law enforcement agency.
The Federal Commission for the Protection against Sanitary Risk (in Spanish, Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS) is a regulatory body of the Mexican government.
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.
The federal government of the United States (U.S. federal government) is the national government of the United States, a constitutional republic in North America, composed of 50 states, one district, Washington, D.C. (the nation's capital), and several territories.
The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) is a medical regulatory body in Germany.
The federal judiciary of the United States is one of the three co-equal branches of the federal government of the United States organized under the United States Constitution and laws of the federal government.
The Federal Register (FR or sometimes Fed. Reg.) is the official journal of the federal government of the United States that contains government agency rules, proposed rules, and public notices.
The Federal Trade Commission (FTC) is an independent agency of the United States government, established in 1914 by the Federal Trade Commission Act.
The First Amendment (Amendment I) to the United States Constitution prevents Congress from making any law respecting an establishment of religion, prohibiting the free exercise of religion, or abridging the freedom of speech, the freedom of the press, the right to peaceably assemble, or to petition for a governmental redress of grievances.
Floyd Abrams (born July 9, 1936) is an American attorney at Cahill Gordon & Reindel.
Food additives are substances added to food to preserve flavor or enhance its taste, appearance, or other qualities.
A food safety agency or food administration is a kind of agency found in various countries and international organizations with responsibilities related to food, primarily with ensuring the safety of food sold or distributed to the population, and with ensuring that food sellers inform the population of the origins and health qualities and risks associated with food being sold.
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007.
The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic 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.
The food industry is a complex, global collective of diverse businesses that supplies most of the food consumed by the world population.
Food safety is a scientific discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness.
Food Safety and Standards Authority of India (FSSAI) is an autonomous body established under the Ministry of Health & Family Welfare, Government of India.
The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec.
Frances Kathleen Oldham Kelsey, CM (July 24, 1914 – August 7, 2015) was a Canadian-American pharmacologist and physician.
Franklin Delano Roosevelt Sr. (January 30, 1882 – April 12, 1945), often referred to by his initials FDR, was an American statesman and political leader who served as the 32nd President of the United States from 1933 until his death in 1945.
Gaucher's disease or Gaucher disease (GD) is a genetic disorder in which glucocerebroside (a sphingolipid, also known as glucosylceramide) accumulates in cells and certain organs.
George Walker Bush (born July 6, 1946) is an American politician who served as the 43rd President of the United States from 2001 to 2009.
Harvey Washington Wiley (October 18, 1844 – June 16, 1930) was a noted American chemist best known for his leadership in the passage of the landmark Pure Food and Drug Act of 1906 and his subsequent work at the Good Housekeeping Institute laboratories.
Headquarters (commonly referred to as HQ or HD) is/are the locations where most, if not all, of the important functions of an organization are coordinated.
Health Canada (Santé Canada) is the department of the government of Canada with responsibility for national public health.
Health care prices in the United States describes market and non-market factors that determine pricing, along with possible causes as to why prices are higher than other countries.
Health informatics (also called health care informatics, healthcare informatics, medical informatics, nursing informatics, clinical informatics, or biomedical informatics) is information engineering applied to the field of health care, essentially the management and use of patient healthcare information.
Health insurance is insurance that covers the whole or a part of the risk of a person incurring medical expenses, spreading the risk over a large number of persons.
Hirudo medicinalis, the European medicinal leech, is one of several species of leeches used as "medicinal leeches".
The human immunodeficiency virus (HIV) is a lentivirus (a subgroup of retrovirus) that causes HIV infection and over time acquired immunodeficiency syndrome (AIDS).
Human immunodeficiency virus infection and acquired immune deficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV).
Ibuprofen is a medication in the nonsteroidal anti-inflammatory drug (NSAID) class that is used for treating pain, fever, and inflammation.
Imiglucerase is a medication used in the treatment of Gaucher's disease.
Imperial Brands plc, formerly Imperial Tobacco Group plc, is a British multinational tobacco company headquartered in Bristol, United Kingdom.
Indoor tanning involves using a device that emits ultraviolet radiation to produce a cosmetic tan.
Informed consent is a process for getting permission before conducting a healthcare intervention on a person, or for disclosing personal information.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.
The International Criminal Police Organization (Organisation internationale de police criminelle; ICPO-INTERPOL), more commonly known as Interpol, is an international organization that facilitates international police cooperation.
The inverse benefit law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed.
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).
The iPLEDGE program is a mandatory distribution program in the United States for isotretinoin (sold under the trade name Accutane, among others).
Isotretinoin, also known as 13-cis-retinoic acid (and colloquially referred to by its former brand name Accutane or Roaccutane), is a medication primarily used to treat severe acne.
"Jim" was the name of a former milk wagon horse, who was used to produce serum containing diphtheria antitoxin (antibodies against diphtheria toxin).
The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.
A laboratory (informally, lab) is a facility that provides controlled conditions in which scientific or technological research, experiments, and measurement may be performed.
A laser is a device that emits light through a process of optical amplification based on the stimulated emission of electromagnetic radiation.
In law, liable means "esponsible or answerable in law; legally obligated." Legal liability concerns both civil law and criminal law and can arise from various areas of law, such as contracts, torts, taxes, or fines given by government agencies.
Libertarianism (from libertas, meaning "freedom") is a collection of political philosophies and movements that uphold liberty as a core principle.
Liberty Fund, Inc. is a nonprofit foundation headquartered in Indianapolis, Indiana which promulgates the libertarian views of its founder, Pierre F. Goodrich through publishing, conferences, and educational resources.
This is a list of agencies of the United States federal government.
Lorillard Tobacco Company was an American tobacco company that marketed cigarettes under the brand names Newport, Maverick, Old Gold, Kent, True, Satin, and Max.
Maggot therapy is a type of biotherapy involving the introduction of live, disinfected maggots (fly larvae) into the non-healing skin and soft tissue wound(s) of a human or animal for the purpose of cleaning out the necrotic (dead) tissue within a wound (debridement) and disinfection.
The Marketed Health Products Directorate (MHPD) is the Canadian federal authority that monitors the safety and effectiveness of health products marketed in Canada.
Mascara is a cosmetic commonly used to enhance the eyelashes.
Medical cannabis, or medical marijuana, is cannabis and cannabinoids that are recommended by doctors for their patients.
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.
A medication (also referred to as medicine, pharmaceutical drug, or simply drug) is a drug used to diagnose, cure, treat, or prevent disease.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
MedWatch is the Food and Drug Administration’s Safety Information and Adverse Event Reporting Program.
The Mercatus Center at George Mason University is an American non-profit free-market-oriented research, education, and outreach think tank directed by Tyler Cowen.
A microwave oven (also commonly referred to as a microwave) is an electric oven that heats and cooks food by exposing it to electromagnetic radiation in the microwave frequency range.
The is a cabinet level ministry of the Japanese government.
A mobile app is a computer program designed to run on a mobile device such as a phone/tablet or watch.
A mobile phone, known as a cell phone in North America, is a portable telephone that can make and receive calls over a radio frequency link while the user is moving within a telephone service area.
A monopoly (from Greek μόνος mónos and πωλεῖν pōleîn) exists when a specific person or enterprise is the only supplier of a particular commodity.
The term muckraker was used in the Progressive Era to characterize reform-minded American journalists who attacked established institutions and leaders as corrupt.
Mylan N.V. is an American global generic and specialty pharmaceuticals company registered in the Netherlands, with principal executive offices in Hatfield, Hertfordshire, UK and global headquarters in Canonsburg, Pennsylvania, US.
Myocardial infarction (MI), commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.
The National Academy of Medicine (NAM), formerly called the Institute of Medicine (IoM), is an American nonprofit, non-governmental organization.
The National Center for Health Research (formerly the National Research Center for Women & Families) is a Washington, D.C.-based non-profit organization founded in 1999.
The National Center for Toxicological Research (NCTR) is the branch of the United States Food and Drug Administration which conducts research to define biological mechanisms of action underlying the toxicity of products regulated by the FDA.
The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research, founded in the late 1870s.
Brazilian Health Regulatory Agency (in Portuguese, Agência Nacional de Vigilância Sanitária) is a regulatory body of the Brazilian government, created in 1999 during President Fernando Henrique Cardoso's term of office.
The Naval Ordnance Laboratory (NOL), now disestablished, formerly located in the White Oak area of Montgomery County, Maryland, was the site of considerable work that had practical impact upon world technology.
Neglected tropical diseases (NTDs) are a diverse group of tropical infections which are especially common in low-income populations in developing regions of Africa, Asia, and the Americas.
Neurostimulation is the purposeful modulation of the nervous system's activity using invasive (e.g. microelectrodes) or non-invasive means (e.g. transcranial magnetic stimulation or transcranial electric stimulation, tES, such as tDCS or transcranial alternating current stimulation, tACS).
The Food and Drug Administration's New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are a drug class that reduce pain, decrease fever, prevent blood clots and, in higher doses, decrease inflammation.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration.
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.
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.
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.
OpenFDA is a project indexing and formatting FDA data, and making it accessible to the public.
Opioids are substances that act on opioid receptors to produce morphine-like effects.
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.
Oxymorphone, sold under the brand names Numorphan among others, is a powerful semi-synthetic opioid analgesic (painkiller) developed in Germany in 1914.
Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use.
Pasteurization or pasteurisation is a process in which packaged and non-packaged foods (such as milk and fruit juice) are treated with mild heat (Today, pasteurization is used widely in the dairy industry and other food processing industries to achieve food preservation and food safety. This process was named after the French scientist Louis Pasteur, whose research in the 1880s demonstrated that thermal processing would inactivate unwanted microorganisms in wine. Spoilage enzymes are also inactivated during pasteurization. Most liquid products are heat treated in a continuous system where heat can be applied using plate heat exchanger and/or direct or indirect use of steam and hot water. Due to the mild heat there are minor changes to the nutritional quality of foods as well as the sensory characteristics. Pascalization or high pressure processing (HPP) and Pulsed Electric Field (PEF) are non-thermal processes that are also used to pasteurize foods.
Pediatrics (also spelled paediatrics or pædiatrics) is the branch of medicine that involves the medical care of infants, children, and adolescents.
A pet or companion animal is an animal kept primarily for a person's company, protection, or entertainment rather than as a working animal, livestock, or laboratory animal.
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.
The is a Japanese governmental organization, similar in function to the Food and Drug Administration (FDA) in the United States or the Medicines and Healthcare products Regulatory Agency in the United Kingdom or the Central Drugs Standard Control Organization (CDSCO) in India or the European Medicines Agency in Europe.
Pharmacokinetics (from Ancient Greek pharmakon "drug" and kinetikos "moving, putting in motion"; see chemical kinetics), sometimes abbreviated as PK, is a branch of pharmacology dedicated to determining the fate of substances administered to a living organism.
A physician, medical practitioner, medical doctor, or simply doctor is a professional who practises medicine, which is concerned with promoting, maintaining, or restoring health through the study, diagnosis, and treatment of disease, injury, and other physical and mental impairments.
Polytetrafluoroethylene (PTFE) is a synthetic fluoropolymer of tetrafluoroethylene that has numerous applications.
Postmarketing surveillance (PMS) (also post market surveillance) is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.
A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed.
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.
The President of the United States (POTUS) is the head of state and head of government of the United States of America.
The Prime Minister of Canada (Premier ministre du Canada) is the primary minister of the Crown, chairman of the Cabinet, and thus Canada's head of government, charged with advising the Canadian monarch or Governor General of Canada on the exercise of the executive powers vested in them by the constitution.
Priority review is a mechanism used by the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease.
The Progressive Era was a period of widespread social activism and political reform across the United States that spanned from the 1890s to the 1920s.
Proteins are large biomolecules, or macromolecules, consisting of one or more long chains of amino acid residues.
Public health is "the science and art of preventing disease, prolonging life and promoting human health through organized efforts and informed choices of society, organizations, public and private, communities and individuals".
The Public Health Service Act is a United States federal law enacted in 1944.
Puerto Rico (Spanish for "Rich Port"), officially the Commonwealth of Puerto Rico (Estado Libre Asociado de Puerto Rico, "Free Associated State of Puerto Rico") and briefly called Porto Rico, is an unincorporated territory of the United States located in the northeast Caribbean Sea.
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.
Richard Joshua "R.
A racket is a planned or organized criminal act, usually in which the criminal act is a form of business or a way to earn illegal or extorted money regularly or briefly but repeatedly.
Radioactive decay (also known as nuclear decay or radioactivity) is the process by which an unstable atomic nucleus loses energy (in terms of mass in its rest frame) by emitting radiation, such as an alpha particle, beta particle with neutrino or only a neutrino in the case of electron capture, gamma ray, or electron in the case of internal conversion.
Regulation is an abstract concept of management of complex systems according to a set of rules and trends.
Robert C. Randall (1948–2 June 2001, Sarasota, Florida, United States) was an advocate for medical marijuana and the founder of Alliance for Cannabis Therapeutics.
Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that has now been withdrawn over safety concerns.
Santa Fe Natural Tobacco Company is an American tobacco manufacturer based in Santa Fe, New Mexico, best known for its production of the premier Natural American Spirit cigarette brand.
The science policy of the United States is the responsibility of many organizations throughout the federal government.
Scott Gottlieb (born June 11, 1972) is an American physician who serves as commissioner of the Food and Drug Administration.
Silver Spring is a city located inside the Capital Beltway in Montgomery County, Maryland, United States.
Sperm donation is the provision (or "donation") by a man (known as a sperm donor) of his sperm (known as donor sperm), principally for it to be used in the artificial insemination of a woman or women who are not his sexual partners.
Stephen Joseph Harper (born April 30, 1959) is a Canadian economist, entrepreneur, and retired politician who served as the 22nd Prime Minister of Canada, from February 6, 2006, to November 4, 2015.
The Supreme Court of the United States (sometimes colloquially referred to by the acronym SCOTUS) is the highest federal court of the United States.
Television (TV) is a telecommunication medium used for transmitting moving images in monochrome (black and white), or in colour, and in two or three dimensions and sound.
Thalidomide, sold under the brand name Immunoprin, among others, is an immunomodulatory drug and the prototype of the thalidomide class of drugs.
The Wall Street Journal is a U.S. business-focused, English-language international daily newspaper based in New York City.
Theodore Roosevelt Jr. (October 27, 1858 – January 6, 1919) was an American statesman and writer who served as the 26th President of the United States from 1901 to 1909.
Title 18 of the United States Code is the main criminal code of the federal government of the United States.
Title 21 of the United States Code governs Food and Drugs in the United States Code (U.S.C.).
Tobacco is a product prepared from the leaves of the tobacco plant by curing them.
Tobacco is the agricultural product of the leaves of plants in the genus Nicotiana.
The toothbrush is an oral hygiene instrument used to clean the teeth, gums, and tongue.
Triamterene (trade name Dyrenium) is a potassium-sparing diuretic used in combination with thiazide diuretics for the treatment of hypertension and edema.
Tuberculosis (TB) is an infectious disease usually caused by the bacterium Mycobacterium tuberculosis (MTB).
The United States Consumer Product Safety Commission (CPSC or Commission) is an independent agency of the United States government.
United States Customs and Border Protection (CBP) is the largest federal law enforcement agency of the United States Department of Homeland Security.
The U.S. Securities and Exchange Commission (SEC) is an independent agency of the United States federal government.
A state is a constituent political entity of the United States.
The United States of America (USA), commonly known as the United States (U.S.) or America, is a federal republic composed of 50 states, a federal district, five major self-governing territories, and various possessions.
Many of the divisions and offices of the United States Department of Justice are headed by an Assistant Attorney General.
The United States Congress is the bicameral legislature of the Federal government of the United States.
The United States Department of Agriculture (USDA), also known as the Agriculture Department, is the U.S. federal executive department responsible for developing and executing federal laws related to farming, forestry, and food.
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.
The United States federal executive departments are the primary units of the executive branch of the Federal government of the United States.
The Committee on Energy and Commerce is one of the oldest standing committees of the United States House of Representatives.
The United States Secretary of Health and Human Services is the head of the United States Department of Health and Human Services, concerned with health matters.
The United States Senate is the upper chamber of the United States Congress, which along with the United States House of Representatives—the lower chamber—comprise the legislature of the United States.
The United States Virgin Islands (USVI; also called the American Virgin Islands), officially the Virgin Islands of the United States, is a group of islands in the Caribbean that is an insular area of the United States located east of Puerto Rico.
Upton Beall Sinclair Jr. (September 20, 1878 – November 25, 1968) was an American writer who wrote nearly 100 books and other works in several genres.
A vaccine is a biological preparation that provides active acquired immunity to a particular disease.
The Vaccine Act of 1813 was an Act of the Twelfth Congress of the United States to encourage vaccination against smallpox.
Veterinary medicine is the branch of medicine that deals with the prevention, diagnosis and treatment of disease, disorder and injury in non-human animals.
The Washington metropolitan area is the metropolitan area centered on Washington, D.C., the capital of the United States.
Washington, D.C., formally the District of Columbia and commonly referred to as Washington or D.C., is the capital of the United States of America.
The West African Ebola virus epidemic (2013–2016) was the most widespread outbreak of Ebola virus disease (EVD) in history—causing major loss of life and socioeconomic disruption in the region, mainly in the countries of Guinea, Liberia, and Sierra Leone.
White Oak is a census-designated place and an unincorporated area in Montgomery County, Maryland.
ZMapp is an experimental biopharmaceutical drug comprising three chimeric monoclonal antibodies under development as a treatment for Ebola virus disease.
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