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  1. What We Do | FDA

    FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health …

  2. U.S. Food and Drug Administration

    The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by …

  3. About FDA | FDA - U.S. Food and Drug Administration

    General information about FDA – its mission, history, organization, partnerships, etc.

  4. What does FDA regulate? - U.S. Food and Drug Administration

    Mar 29, 2024 · FDA regulates medical products, most food (except some meats, poultry, and egg products that are regulated by the USDA), tobacco, products that give off radiation, cosmetics, …

  5. Facts About the Current Good Manufacturing Practice (CGMP) | FDA

    Nov 21, 2025 · CGMP, regulations enforced by FDA, provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

  6. Investigational Device Exemption (IDE) | FDA

    Aug 22, 2024 · An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a …

  7. Development & Approval Process | Drugs | FDA

    Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.

  8. Biologics License Applications (BLA) Process (CBER) | FDA

    FDA Form 3674 Federal Register Notice: New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not …

  9. Emergency Use Authorization for Vaccines Explained | FDA

    FDA recognizes the gravity of the current public health emergency and the importance of facilitating availability, as soon as possible, of vaccines to prevent COVID-19 - vaccines that …

  10. Import Basics | FDA

    Dec 11, 2024 · The FDA regulates a variety of products including: food, medical products (such as drugs, devices, and biological products), radiation-emitting electronic products, animal feed, …