FDA announced 7 new clinical trial grants under the Orphan Products Grants Program. This program has supported clinical research for rare diseases since 1983, resulting in FDA approval or clearance of more than 85 drugs, biologics, and devices for rare diseases: https://lnkd.in/dmujet9c FDA also awarded three new natural history study grants, providing approximately $4.7 million over four years to advance the understanding of how specific rare diseases progress over time: https://lnkd.in/dRckbH7v
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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Are you interested in AI to support postmarket drug safety research? Check out this publication which discusses a novel AI tool created and validated by FDA that could enable researchers to efficiently identify and analyze safety-related drug labeling changes: https://lnkd.in/gjUi-RkY We envision that the tool can increase efficiency for identifying safety-related labeling changes. This tool is part of BERTox (https://lnkd.in/eUePjp8J), an initiative of the NCTR-developed AI4TOX program (https://lnkd.in/esBC8WAi) that aims to apply the most advanced AI methods to develop new tools to support FDA regulatory science and strengthen the safety review of FDA-regulated products. This research was conducted by authors George A. Neyarapally, Leihong Wu, Joshua Xu, Esther H. Zhou, Oanh Dang, Joann Lee, Dharmang Mehta, Rochelle D. Vaughn, Ellen Pinnow, and Hong Fang.
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Want to learn more about our final guidance, Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies? Check out our guidance snapshot & podcast which reviews FDA’s recommendations including: ✅ whether and when to do the study ✅ designing the study ✅ reporting results 📷 Guidance Snapshot: https://lnkd.in/eK2E_6xk 🔊 Guidance Recap Podcast: https://lnkd.in/eqJjUpPj 📖 Podcast Transcript: https://lnkd.in/ezcSR-Em
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Drug addiction can happen to anyone. You can help. Prescribe medications for opioid use disorder. Learn more at: https://lnkd.in/eaE8DRvf. #PrescribeWithConfidence #Addiction #MOUD
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📢 Are you treating patients with rheumatic conditions? This new course can help. Learn how biosimilars can be used in patient care plans and how to address patient hesitancy. Enroll now: https://bit.ly/4gs11wn
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FDA released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. This report aggregates metrics for regulatory activities supported by GDUFA research in three areas where the GDUFA Science and Research Program is expected to make an impact: ✅ Supporting the Pharmaceutical Development of Generic Drug Products ✅ Generating Evidence to Support the Timely Review and Approval of ANDAs ✅ Establishing More Efficient Approaches to Evaluate the Equivalence of Generic Drugs Read the FY23 GDUFA Science and Research Outcomes Report: https://lnkd.in/eCbDsJRG
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Watch our recorded webinar to find step-by-step information and best practices for completing and submitting Form FDA 1571 and IND cover letters for OTP-regulated products. And find other useful resources from our OTP Learn Course List! https://bit.ly/4dS1INE
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The FDA’s Center for Devices and Radiological Health (CDRH) is announcing the expansion of the Total Product Life Cycle Advisory Program Pilot. Breakthrough Designated Devices reviewed in the Office of Radiological Health (OHT8) and the Division of Ophthalmic Devices (DHT1A) are eligible to enroll in the TAP Pilot. Find out more. https://lnkd.in/e7dhFvjG Additionally, CDRH is providing a resource: TAP Pilot Engagement Tips that is intended to provide considerations that may help foster engagement between medical device sponsors and non-FDA parties including patients, payers, and health care providers during the medical device design and development process. https://lnkd.in/eKTz9Wiu
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Today, the FDA’s Human Foods Program #HFP is launching a new streamlined approach for handling and tracking complaints to improve the ability to detect and respond to problems involving FDA-regulated foods and dietary supplements, including infant formula. https://lnkd.in/eav44FC5 Through this new process, the FDA will be better able to interface with consumers, learn new and valuable information about FDA-regulated products, and deliver on its mission to protect and promote public health through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure the safety of chemicals in food more effectively. There are now two ways to report food/dietary supplement issues: (1) through the #SafetyReportingPortal https://lnkd.in/dus53uu or (2) a call to 1-888-SAFEFOOD. NOTE: consumers and medical community who previously made reports through the FDA’s Office of Regulatory Affairs (ORA) hotline, should now use only 1-888-SAFEFOOD.
FDA Introduces Streamlined Complaint Process in new HFP
fda.gov
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Today, the first video in the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) educational video series was released. This first video titled, "Challenges, Strategies, and Regulatory Considerations for the Design of Rare Disease Clinical Trials” provides an overview of FDA’s regulatory requirements and strategies for clinical trial design. The ARC Program initiated LEADER 3D to better understand the unique challenges in bringing rare disease products to market. This video series and other educational resources will assist those navigating these scientific challenges and designing rare disease clinical trials that meet FDA’s regulatory requirements. Learn more & view video here: https://lnkd.in/eEW-xreB
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