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About us
The Food and Drug Administration is an agency within the Department of Health and Human Services. 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 ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. 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 threats.
- Website
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http://www.fda.gov/
External link for FDA
- Industry
- Government Administration
- Company size
- 10,001+ employees
- Headquarters
- Silver Spring, MD
- Type
- Government Agency
- Specialties
- Food, Drugs, Medical Devices, Vaccines Blood and Biologics, Animal and Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products, Regulatory Research, and Toxicological Regulatory Research
Locations
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Primary
Get directions
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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FDA is warning consumers to not purchase or use Skin-Cap aerosol spray products because they may contain undisclosed steroids: https://lnkd.in/ev6b_kyP
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Today, FDA is announcing a set of key deliverables that the Human Foods Program #HFP will prioritize in FY 2025 within the context of our program’s design and responsibilities. The HFP’s vision is to ensure that food serves as a vehicle for wellness, and our day-to-day activities support our mission to protect and promote the health and wellness of all people through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure chemicals in food are safe. In FY2025 we will continue to build a multi-year strategic plan to advance the HFP’s vision and mission. https://lnkd.in/eefNbssj
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FDA published additional resources for the Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development Guidance for Industry. This guidance provides a framework for considering neurodevelopmental evaluations that could be useful to assess long-term safety of a medical product intended for use in neonates. The resources include a snapshot, recap podcast, and podcast transcript about the guidance ⬇ 📷 Guidance Snapshot: https://lnkd.in/eqQBVHct 🎧 Guidance Podcast: https://lnkd.in/esHVtjBY 📙 Guidance Transcript: https://lnkd.in/ei7-9Wjh
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As #CyberMonth comes to an end, remember that cybersecurity incidents can affect patients by impacting medical device availability and functionality. The health care environment is complex, and manufacturers, hospitals, and facilities should work together to manage cybersecurity risks to assure safe and effective medical devices for everyone. Learn more: https://bit.ly/3AgWlJj
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The FDA’s Digital Health Center of Excellence (DHCoE) is leading the advancement of #DigitalHealth to protect and promote public health. Check out the latest edition of DHCoE’s newsletter: https://lnkd.in/ey9nc3SB
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On 10/30, FDA announced that the agency issued warning letters to nine online retailers and one manufacturer for selling and/or distributing unauthorized disposable e-cigarettes with designs and functionalities that resemble smart technology, including phones and gaming devices. https://lnkd.in/ddZiVTsi This latest round of warning letters marks another step in FDA’s continued efforts to remove unauthorized e-cigarette products from the market, particularly those that appeal to youth. To date, FDA has issued more than 700 warning letters to firms for manufacturing, selling, and/or distributing unauthorized new tobacco products, issued more than 690 warning letters to retailers for the sale of unauthorized tobacco products, and filed civil money penalty complaints against more than 75 manufacturers and more than 150 retailers for distribution and/or sale of unauthorized tobacco products.
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FDA published the guidance for industry, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides recommendations to generic drug applicants for conducting bioequivalence (BE) studies for orally administered immediate-release solid dosage forms. BE assessment for these oral dosage forms is important for establishing therapeutic equivalence for generic drug products to their respective comparator products. M13A represents the first harmonized guidance for BE. To facilitate implementation of the guidance, a supplemental questions and answers document was published to clarify concepts and rationales covered in the guidance. Learn more: https://lnkd.in/d-ZRCwsu