On June 5, 2024, we will host a webinar to provide an overview of two draft guidances on enforcement policies for certain in vitro diagnostic devices: ☑ Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 ☑ Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency. Find out more: https://lnkd.in/emGWYqis
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
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10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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In the latest issue of CTPConnect: FDA’s Center for Tobacco Products (CTP) commemorates 10 years of “The Real Cost” youth tobacco prevention campaign with an upcoming webinar; plus, a recent podcast episode explores the impact of the campaign. Read more and subscribe to get notified about tobacco regulation news and announcements from FDA: https://lnkd.in/dXzhHdXv
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📣 FDA is alerting patients, caregivers, and health care professionals of labeling updates for glatiramer acetate injection products. Updated labeling includes a new warning that using an autoinjector that is not compatible with a specific glatiramer acetate injection product may increase the risk for medication errors, such as a missed dose or administration of a partial dose. FDA is also alerting patients and health care professionals that some glatiramer acetate injection products may be administered using an optional compatible autoinjector, while other glatiramer acetate injection products must only be injected using the prefilled syringe. Learn more:
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Our Center for Devices and Radiological Health qualified a new patient-reported outcome instrument through the Medical Device Development Tools (MDDT) program. The Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) instrument assesses frequency and bother of ocular symptoms in certain patients undergoing intraocular lens implant. Find out more about the new tool. https://lnkd.in/ez73KUmN
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Learn more about the new CDER Center for Clinical Trial Innovation (C3TI). C3TI is a central hub that supports innovative approaches to clinical trials to improve the efficiency of drug development. C3TI aims to promote existing CDER programs and spur future innovation activities through enhanced communication and collaboration, with the ultimate goal of accelerating the developing of safe and effective new drugs.
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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
OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Product
fda.gov
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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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