Today, FDA published a new draft guidance for industry, Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs: https://lnkd.in/eCR-AnNW This guidance recommends how applicants can provide complete information with the goal of minimizing the number of assessment cycles and communications that are necessary for approval, as well as ensuring product labels are clear. FDA is issuing this guidance as part of our Drug Competition Action Plan, which seeks to expand access to safe, high-quality, effective generic medicines that can help consumers lower their health care costs: https://lnkd.in/dM8f6ydU
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
- 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
- Primary
Get directions
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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FDA approved the 50th biosimilar and released the new Biosimilars Action Plan (BAP). Learn more about FDA's ongoing commitment to foster the development of biosimilars by visiting the latest edition of the FDA Voices: https://lnkd.in/gXDPhKW9 Since FDA’s biosimilars program started, the agency has contributed to the growth of biosimilar adoption and the increasing availability of therapeutic options for patients who face increasing costs and restrictions to access much needed medications. FDA has approved biosimilars to treat a wide range of conditions such as diabetes, skin conditions, bowel disorders, and more. These treatment options can give patients access to life-saving or life-sustaining treatment at potentially reduced costs. FDA has also released its revised BAP to facilitate the efficient development and approval of biosimilars, maximize scientific and regulatory clarity, improve understanding, and support market competition: https://lnkd.in/g4qNpyJ6 Our revised BAP reinforces the agency’s commitments to these important initiatives and our commitment to the continued development and approval of high quality, safe, and effective biosimilars for the American public.
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Ever wondered how FDA could use Large Language Models and Artificial Intelligence in our regulatory work? Check out this publication to see how we can leverage these tools to provide a more efficient, accurate, and reliable solution for extracting relevant information from drug labeling documents: https://lnkd.in/gNBpwx38 This research was conducted by Leihong Wu, Joshua Xu, Shraddha Thakkar, Magnus Gray, Yanyan Qu, Dongying L., and Tong Weida.
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In the latest issue of CTPConnect: A new commentary from the Director of FDA’s Center for Tobacco Products (CTP) on the relative risks of tobacco products, the launch of a searchable database of tobacco products, and the announcement of new leadership within CTP. Read more and subscribe to get notified about tobacco regulation news and announcements from FDA: https://lnkd.in/dqBdEniF
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By reporting suspected false or misleading prescription drug promotion, you can help ensure that the information you’re relying on is truthful and not misleading: http://www.fda.gov/BadAd #FDABadAd
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With direct-to-consumer tests, patients have increased access to monitor their health conveniently at home without the involvement of a health care provider. As a result, patients may have questions about their test results. On National DNA Day, we remind you to talk to your patients about direct-to-consumer tests — including genetic tests — and help them understand the benefits, as well as the limitations of certain tests. Learn more: https://lnkd.in/e5sUrS-f
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The FDA has REOPENED the comment period on the draft guidance “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE,” Submit either electronic or written comments on the draft guidance by June 25, 2024, to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance. https://lnkd.in/eb6uaVc5
Draft Guidance on Sampling Recommendations for Seafood Subject to DWPE
fda.gov
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We’re participating in Bring Your Child to Work Day and want to “Inspire 2 Aspire.” Today provides an opportunity for the next generation of scientists and innovators to explore the FDA’s different Centers. We invite you to learn more about how our Center for Devices and Radiological Health (CDRH) assures that patients have access to safe, effective, and high-quality #MedicalDevices. Check out this video: https://lnkd.in/g8VVt92b #BYCTWD #Inspire2Aspire
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Public Workshop: How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases. AACR Past President Dr. Elizabeth Jaffee and FDA Oncology Center's Dr. Harpreet Singh chair this American Association for Cancer Research and U.S. FDA workshop workshop on May 9 in Bethesda, MD, or online. Learn more and sign up: https://lnkd.in/eggUzU3H