Question: “What are some of the challenges observed in nonclinical studies that could later affect IND submissions?” Find the answer to this question & more from our #CBEROTP Virtual Town Hall on nonclinical assessment for cell and #GeneTherapy products. https://bit.ly/46AOMHo
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
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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Did you the FDA has a database of nearly all drugs that have been approved since 1939? Download the Drugs@FDA free mobile app to access patient information, labels, approval letters, reviews, and more. Get the app ➡️ https://lnkd.in/dkHf9pND
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Join FDA and Reagan-Udall Foundation for the FDA on May 30, 2024, at 2:00 PM ET for a public webinar to discuss the draft guidance, “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products.” 📅 Register for the webinar: https://lnkd.in/e-Bvag9T 📑 Read the draft guidance: https://lnkd.in/ePhZT_Ui
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FDA released the "2023 Drug Trials Snapshots Summary Report", providing information on the diversity of participants in clinical trials that led to novel drug approvals. The approved therapies span a wide range of medical conditions including ones that largely affect pediatric patients, diseases affecting only males or females, common diseases that affect a large proportion of the population in the United States. (U.S.), and rare (or orphan) diseases with a smaller number of patients in the U.S. and around the world. 🔎 Learn more: https://lnkd.in/dwTFDvw 💭 Share your thoughts by sending an email to Snapshots@fda.hhs.gov
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FDA invites the public to register for a webinar on basic mushroom growing, harvesting, holding, and packing activities under the Produce Safety Rule Speakers include: - Kristin Esch, Produce Safety Expert, Center for Food Safety and Applied Nutrition (CFSAN), FDA (Moderator) - John Pecchia Ph.D., Mushroom Research Center and Spawn Laboratory in the Department of Plant Pathology, Penn State University - Maria Gorgo-Simcox, Food Safety, IPM and Water Quality Extension Educator & Affiliate Instructor, Plant Pathology and Environmental Microbiology, Penn State University - Wendy Read, Food Safety Inspector, Pennsylvania Department of Agriculture
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This #NationalWomensHealthWeek, we recognize the importance of women’s health research. Learn how the FDA promotes and conducts research initiatives that advance the understanding of sex differences and health conditions unique to women: https://lnkd.in/eCUy8PqF
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We’re in Fort Worth for #NABP2024! Stop by our National Association of Boards of Pharmacy Table Top Exhibit to learn what’s new with FDA.
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Now available: New #CBEROTP draft guidance on “Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products.” Review the guidance and submit comments by July 29, 2024. https://bit.ly/49TKblq
Human and Animal Derived Materials
fda.gov
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We’re in Orlando for the IHI Patient Safety Congress. Stop by Exhibit #319 to learn about recent drug safety information, recalls, shortages, and much more. #IHIPatientSafetyCongress
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You can still register for the 2024 Regulatory Education for Industry (REdI) Conference June 5-9. The conference will be recorded on YouTube Live and available to view after the event has concluded each day: https://lnkd.in/gV5PvVmy #MedicalDevice #FDA