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FDA warning letter

Index 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. [1]

65 relations: Abbreviated New Drug Application, Administrative detention, Adulterant, Adverse drug reaction, Advertising, Application software, Biologics license application, Biopharmaceutical, Blood donation, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine, Civil penalty, Compounding, Confidentiality, Corrective and preventive action, Dosage form, Federal Food, Drug, and Cosmetic Act, Federal Trade Commission, FedEx, Felony, Food and Drug Administration, Form FDA 483, Formulation, Fraud, Freedom of information, Freedom of Information Act, Good manufacturing practice, HBsAg, Hepatitis C virus, HIV, Injunction, Inspection, Institutional review board, Internet, Internet-related prefixes, Investigational New Drug, Library, List of distinct cell types in the adult human body, Medical gas supply, New Drug Application, Office of In Vitro Diagnostics and Radiological Health, Packaging and labeling, Pesticide residue, Potency (pharmacology), Prescription drug, Prescription Drug Marketing Act, Product recall, Redaction, ..., Regulatory compliance, Return receipt, Search and seizure, Software, Subtypes of HIV, Summary offence, Supplement (publishing), Tamper-evident technology, Therapy, Tissue (biology), Title 18 of the United States Code, United States, United States Department of Health and Human Services, Virus, Voluntary compliance. Expand index (15 more) »

Abbreviated New Drug Application

An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.

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Administrative detention

Administrative detention is arrest and detention of individuals by the state without trial, usually for security reasons.

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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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Adverse drug reaction

An adverse drug reaction (ADR) is an injury caused by taking a medication.

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Advertising

Advertising is an audio or visual form of marketing communication that employs an openly sponsored, non-personal message to promote or sell a product, service or idea.

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Application software

An application software (app or application for short) is a computer software designed to perform a group of coordinated functions, tasks, or activities for the benefit of the user.

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Biologics license application

A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2).

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Biopharmaceutical

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.

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Blood donation

A blood donation occurs when a person voluntarily has blood drawn and used for transfusions and/or made into biopharmaceutical medications by a process called fractionation (separation of whole-blood components).

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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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Center for Veterinary Medicine

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.

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Civil penalty

A civil penalty or civil fine is a financial penalty imposed by a government agency as restitution for wrongdoing.

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Compounding

Pharmaceutical compounding (done in compounding pharmacies) is the creation of a particular pharmaceutical product to fit the unique need of a patient.

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Confidentiality

Confidentiality involves a set of rules or a promise usually executed through confidentiality agreements that limits access or places restrictions on certain types of information.

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Corrective and preventive action

Corrective and preventive action (CAPA, also called Corrective Action / Preventive Action, or simply Corrective Action) are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations.

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Dosage form

Dosage forms (also called unit doses) are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components (excipients), in a particular configuration (such as a capsule shell, for example), and apportioned into a particular dose.

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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.

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Federal Trade Commission

The Federal Trade Commission (FTC) is an independent agency of the United States government, established in 1914 by the Federal Trade Commission Act.

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FedEx

FedEx Corporation is an American multinational courier delivery services company headquartered in Memphis, Tennessee.

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Felony

The term felony, in some common law countries, is defined as a serious crime.

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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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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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Formulation

Formulation is a term used in various senses in various applications, both the material and the abstract or formal.

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Fraud

In law, fraud is deliberate deception to secure unfair or unlawful gain, or to deprive a victim of a legal right.

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Freedom of information

Freedom of information is an extension of freedom of speech, a fundamental human right recognized in international law, which is today understood more generally as freedom of expression in any medium, be it orally, in writing, print, through the Internet or through art forms.

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Freedom of Information Act

Freedom of Information Act may refer to the following legislations in different jurisdictions which mandate the national government to disclose certain data to the general public upon request.

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Good manufacturing practice

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.

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HBsAg

HBsAg (also known as the Australia antigen) is the surface antigen of the hepatitis B virus (HBV).

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Hepatitis C virus

Hepatitis C virus (HCV) is a small (55–65 nm in size), enveloped, positive-sense single-stranded RNA virus of the family Flaviviridae.

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HIV

The human immunodeficiency virus (HIV) is a lentivirus (a subgroup of retrovirus) that causes HIV infection and over time acquired immunodeficiency syndrome (AIDS).

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Injunction

An injunction is an equitable remedy in the form of a court order that compels a party to do or refrain from specific acts.

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Inspection

An inspection is, most generally, an organized examination or formal evaluation exercise.

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Institutional review board

An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical.

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Internet

The Internet is the global system of interconnected computer networks that use the Internet protocol suite (TCP/IP) to link devices worldwide.

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Internet-related prefixes

Internet-related prefixes such as e-, i-, cyber-, info-, techno- and net- are added to a wide range of existing words to describe new, Internet- or computer-related flavors of existing concepts, often electronic products and services that already have a non-electronic counterpart.

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Investigational New Drug

The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

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Library

A library is a collection of sources of information and similar resources, made accessible to a defined community for reference or borrowing.

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List of distinct cell types in the adult human body

There are many different types of cell in the human body.

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Medical gas supply

Medical gas supply systems in hospitals and other healthcare facilities are utilized to supply specialized gases and gas mixtures to various parts of the facility.

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New Drug Application

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.

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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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Packaging and labeling

Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use.

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Pesticide residue

Pesticide residue refers to the pesticides that may remain on or in food after they are applied to food crops.

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Potency (pharmacology)

In the field of pharmacology, potency is a measure of drug activity expressed in terms of the amount required to produce an effect of given intensity.

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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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Product recall

A product recall is a request to return a product after the discovery of safety issues or product defects that might endanger the consumer or put the maker/seller at risk of legal action.

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Redaction

Redaction is a form of editing in which multiple source texts are combined (redacted) and altered slightly to make a single document.

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Regulatory compliance

In general, compliance means conforming to a rule, such as a specification, policy, standard or law.

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Return receipt

In e-mail, the term return receipt is somewhat misleading.

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Search and seizure

Search and Seizure is a procedure used in many civil law and common law legal systems by which police or other authorities and their agents, who, suspecting that a crime has been committed, commence a search of a person's property and confiscate any relevant evidence found in connection to the crime.

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Software

Computer software, or simply software, is a generic term that refers to a collection of data or computer instructions that tell the computer how to work, in contrast to the physical hardware from which the system is built, that actually performs the work.

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Subtypes of HIV

One of the obstacles to treatment of the human immunodeficiency virus is its high genetic variability.

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Summary offence

A summary offence is a crime in some common law jurisdictions that can be proceeded against summarily, without the right to a jury trial and/or indictment (required for an indictable offence).

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Supplement (publishing)

A supplement is a publication that has a role secondary to that of another preceding or concurrent publication.

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Tamper-evident technology

Tamper-evident describes a device or process that makes unauthorized access to the protected object easily detected.

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Therapy

Therapy (often abbreviated tx, Tx, or Tx) is the attempted remediation of a health problem, usually following a diagnosis.

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Tissue (biology)

In biology, tissue is a cellular organizational level between cells and a complete organ.

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Title 18 of the United States Code

Title 18 of the United States Code is the main criminal code of the federal government of the United States.

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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.

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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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Virus

A virus is a small infectious agent that replicates only inside the living cells of other organisms.

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Voluntary compliance

Voluntary compliance is one of possible ways of practicing corporate social responsibility.

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FDA Warning Letter.

References

[1] https://en.wikipedia.org/wiki/FDA_warning_letter

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