FDA

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services. The FDA 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's origins can be traced back to the passage of the Pure Food and Drug Act in 1906, which was a response to public outcry over unsanitary conditions in the food and drug industries. The agency was officially named the Food and Drug Administration in 1930.

Organization

The FDA is divided into several offices and centers, each responsible for different aspects of its regulatory functions. These include:

• Center for Drug Evaluation and Research (CDER)
• Center for Biologics Evaluation and Research (CBER)
• Center for Devices and Radiological Health (CDRH)
• Center for Food Safety and Applied Nutrition (CFSAN)
• Center for Tobacco Products (CTP)
• Center for Veterinary Medicine (CVM)
• Office of Regulatory Affairs (ORA)

Responsibilities

The FDA's primary responsibilities include:

• Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
• Ensuring the safety of the nation's food supply, cosmetics, and products that emit radiation.
• Regulating the manufacturing, marketing, and distribution of tobacco products.
• Advancing public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable.
• Helping the public get accurate, science-based information they need to use medicines and foods to improve their health.

Regulatory Process

The FDA's regulatory process involves several steps, including:

• Pre-market approval: Before a new drug, biologic, or medical device can be marketed, it must undergo rigorous testing and review to ensure its safety and effectiveness.
• Post-market surveillance: After a product is approved, the FDA continues to monitor its safety and effectiveness through adverse event reporting systems and other mechanisms.
• Enforcement: The FDA has the authority to take enforcement actions, such as issuing warning letters, seizing products, and pursuing criminal prosecutions, to ensure compliance with its regulations.

Related Pages

• United States Department of Health and Human Services
• Pure Food and Drug Act
• Center for Drug Evaluation and Research
• Center for Biologics Evaluation and Research
• Center for Devices and Radiological Health
• Center for Food Safety and Applied Nutrition
• Center for Tobacco Products
• Center for Veterinary Medicine
• Office of Regulatory Affairs