Food and Drug Administration

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This is a Glossary page for the RPS Project

The U.S. Food and Drug Administration (FDA) is the United States Regulatory Authority that controls the manufacture, quality and distribution of drugs, biological medical products, medical devices, foods, dietary supplements, vaccines, blood products, veterinary products and cosmetics. It is a division of the U.S. Department of Health and Human Services.

The FDA is one of the four regulatory members of the International Conference on Harmonisation (ICH), along with the European Medicines Agency (EMEA), the European Commission and the Japanese Ministry of Health, Labor and Welfare (MHLW).

FDA is the sponsor of the HL7 Regulated Product Submissions Project.

Food and Drug Administration Organization

The U.S. FDA consists of the following major subdivisions:

The Office of the Commissioner

The commissioner is a presidential appointment. Currently, the commissioner is Andrew von Eschenbach.

Center for Drugs Evaluation and Review (CDER)

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Center for Biologics Evaluation and Review (CBER)

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Center for Food Safety and Applied Nutrition (CFSAN)

This branch regulates food, dietary supplements, food additives, and cosmetics. From the viewpoint of the RPS project, the areas of most concern are food additives and cosmetics, which require regulatory approval to be marketed.

Information on the current process of electronic submissions of Food and Color Additives to CFSAN can be found on the FDA website: [1], and uses form FDA Form 3503 for Food Additives and FDA Form 3504 for Color Additives.

There are no current procedures for electronic filing of Dietary Supplements, Food Labeling or Cosmetics. All CFSAN guidance can be found here: [2]

Center for Veterinary Medicine (CVM)

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Center for Devices and Radiological Health (CDRH)

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National Center for Toxicological Research (NCTR)

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Office of Regulatory Affairs (ORA)

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External Links