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.
External link for FDA
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Silver Spring, MD 20993, US
🔔 Test your knowledge in anticipation of our upcoming Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development on May 29-30, 2024, by responding to the question below. The answer will be posted once the poll closes. ☑ Register to attend: https://lnkd.in/e6yYMTUZ
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Check out the May issue of the OCE PULSE for updates from the FDA Oncology Center of Excellence about upcoming meetings, presentations, oncology drug approvals, and publications. https://lnkd.in/esX6NMa7 Subscribe for free at the link. #OCEProjectSocrates #MedEd #OCEPULSE
FDA approves the first drug to treat patients aged 12 years and older with WHIM syndrome, a rare disorder that can lead to recurrent, life-threatening infections: https://lnkd.in/eeQ4EkSA
Today, we announced we will host a listening session in June as part of broader work to optimize the use of, and processes for, advisory committees. https://lnkd.in/efjpVRrC This virtual public meeting will focus on the composition of advisory committees, ways to improve the experience for members serving on committees, and ways to ensure public awareness and understanding of the role of FDA advisory committees.
On May 14, 2024, we will host a webinar to provide an overview of the final rule regarding laboratory developed tests, or LDTs. If you have questions about this final rule that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by May 7, 2024, to be considered for the discussion. Questions will be not be taken during the live webinar. https://lnkd.in/etC3Kh9n
🎧 Learn about FDA’s recent oncology treatment approval of Enhertu (fam-trastuzumab deruxtecan-nxki) in the latest #FDADISCO podcast: https://lnkd.in/gHjDDyAZ
Today, we took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years. https://lnkd.in/eysanFET
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
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.