Today, FDA published the FY 2023 Generic Drug User Fee Amendments (GDUFA) Science and Research Report summarizing the scientific progress and research outcomes that support the development and assessment of generic drugs: https://lnkd.in/efVXP2aa GDUFA research provided the scientific foundation for the approval of complex generic drugs, such as medicines used to treat patients with alcohol use disorder and opioid dependence. GDUFA research helps FDA establish new approaches for manufacturers to develop generic drugs that were previously too challenging to develop, which helps make more generic medicines available. Read the report for more information.
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.
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http://www.fda.gov/
External link for FDA
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- Silver Spring, MD
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- Food, Drugs, Medical Devices, Vaccines Blood and Biologics, Animal and Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products, Regulatory Research, and Toxicological Regulatory Research
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Updates
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Do you currently treat patients with opioid use disorder? ✔ Yes, and it has been successful! ✔ Yes, but only a few patients. ✔ No, I am too busy and not sure where to start. ✔ I am passionate about treating patients with opioid use disorder but am not a prescriber. FDA is launching a new campaign that aims to help primary care providers recognize and treat opioid use disorder (OUD). Visit our website to find free training, firsthand testimonials, and other resources to help providers get started: https://lnkd.in/d-W9FV-F. Prescribe with Confidence: Patients with Opioid Use Disorder Need You. Drop your success stories, your challenges, and your inspiration in the comments. #Prescribewithconfidence
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Calling all CBER sponsors! Embark on a journey of #Innovation. Submit a proposal to the FDA RDEA Pilot Program. Your experience in novel endpoint development could advance #RareDisease #DrugDevelopment for everyone. Apply today! bit.ly/48UBUx4
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Discover how a very, very tiny glass slide and an “organ on a chip” are helping scientists reduce animal testing in drug development. Visit our YouTube page to see more of our Researching FDA video series. https://lnkd.in/eyf8MXEj
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Check out the latest regulatory educational materials from the FDA’s Center for Devices and Radiological Health. The Division of Industry and Consumer Education (DICE) in CDRH provides resources with informative updates about medical devices and radiation-emitting products. https://lnkd.in/e_s2jV24
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#ICYMI: View the recordings from the Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes webinar to learn how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. View the recordings here ➡ https://lnkd.in/eBJNg82z
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When will the facilities first registered with FDA on or after the declaration of the COVID-19 PHE for the sole purpose of producing hand sanitizer products during the COVID-19 PHE need to cease production of hand sanitizer products and deregister from FDA's eDRLS to avoid FY 2025 facility fees? A. Cease production of hand sanitizer products and update registration and listing accordingly, before 12:00 a.m. EST on December 31, 2024 B. No need to do anything C. 45 days after the publication of the federal register notice D. None of the above 💡 Test your knowledge in anticipation of our upcoming OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration by responding to the question below. The answer will be posted once the poll closes. Register to attend the webinar ➡ https://lnkd.in/dafKebhU
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Portable bed rails can be helpful for adults, aged 65 and older, at home, as well as in assisted living facilities and residential care facilities. However, some people are at a higher risk for entrapment, falls, or injuries from using bed rails. To prevent injuries, regularly assess that bed rails remain appropriately matched to the equipment and to the person’s individual needs, considering all relevant risk factors. Check out the FDA’s safety recommendations for health care providers using portable bed rails: https://lnkd.in/eUVu6nPA #OlderAmericansMonth
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#CBEROTP has published a new draft guidance with recommendations regarding safety testing of human allogeneic cells expanded for use in cell-based medical products. Sponsors can review the guidance and submit comments to the docket through July 29, 2024. https://bit.ly/3xVD3HP
Safety Testing of Human Allogeneic Cells
fda.gov