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Glossary

Food and Drug Administration (FDA or USFDA)

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The FDA is a Federal agency within US Department of Health and Human Services, which is the primary regulating body of Food and Drug substances in the USA.

Food and Drug Administration

The FDA consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations. The scope of FDA’s regulatory authority is very broad. FDA’s responsibilities are closely related to those of several other government agencies. The FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico.

FDA is responsible for

  • Protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective
  • Protecting the public from electronic product radiation
  • Assuring cosmetics and dietary supplements are safe and properly labeled
  • Regulating tobacco products
  • Advancing the public health by helping to speed product innovations

FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.

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C

Clinical Study Report (CSR)

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D

Development international birth date (DIBD)

Date of first approval (or authorization) for conducting an interventional clinical trial in any country…

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