USFDA

United States Food and Drug Administration

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Formed	June 30, 1906
Dissolved
Type
Jurisdiction	Federal government of the United States
Status
Headquarters	Silver Spring, Maryland, U.S.

The United States Food and Drug Administration (USFDA) is a federal agency of the Department of Health and Human Services. It is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products.

History

The FDA was formed in 1906, following the passage of the Pure Food and Drug Act, which was a response to public outcry over unsanitary conditions in the food and drug industries. The agency's origins can be traced back to the Bureau of Chemistry in the United States Department of Agriculture, which was established in 1862.

Functions

The FDA's primary functions include:

• Regulation of Food Safety: Ensuring that the food supply is safe, sanitary, and properly labeled.
• Regulation of Drugs and Biologics: Approving new drugs and biologics, ensuring they are safe and effective.
• Medical Devices: Regulating the safety and effectiveness of medical devices.
• Tobacco Products: Regulating the manufacture, distribution, and marketing of tobacco products.
• Cosmetics: Ensuring that cosmetics are safe and properly labeled.
• Veterinary Products: Regulating animal drugs, animal feed, and veterinary devices.

Organizational Structure

The FDA is organized into several offices and centers, each responsible for specific areas of regulation:

• Center for Drug Evaluation and Research (CDER): Oversees the approval of new drugs.
• Center for Biologics Evaluation and Research (CBER): Regulates biological products including vaccines and blood products.
• Center for Devices and Radiological Health (CDRH): Regulates medical devices and radiation-emitting products.
• Center for Food Safety and Applied Nutrition (CFSAN): Ensures the safety of food and cosmetics.
• Center for Tobacco Products (CTP): Regulates tobacco products.

Regulatory Process

The FDA's regulatory process involves several steps:

1. Preclinical Research: Before testing a drug in humans, researchers must conduct laboratory and animal studies. 2. Investigational New Drug Application (IND): Researchers must submit an IND to the FDA before beginning clinical trials. 3. Clinical Trials: Conducted in three phases to assess the drug's safety and effectiveness. 4. New Drug Application (NDA): If clinical trials are successful, a company submits an NDA for FDA review. 5. Post-Market Surveillance: After approval, the FDA continues to monitor the drug's safety.

Impact and Challenges

The FDA plays a crucial role in ensuring public health, but it faces challenges such as balancing the need for rapid drug approval with ensuring safety, managing limited resources, and adapting to new scientific developments.

Also see

• Pure Food and Drug Act
• Department of Health and Human Services
• Center for Drug Evaluation and Research
• Center for Biologics Evaluation and Research
• Center for Devices and Radiological Health