Join FDA & the Center for Research on Complex Generics on Nov. 6-7 for the "Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities and Bioequivalence Assessment for Reformulated Drug Products" event! Stay updated on the latest regulatory requirements and industry trends: https://lnkd.in/ed8y237A Network with experts and peers to discuss the latest nitrosamine research, recommendations, and best practices for ensuring drug safety, efficacy, and quality. Register now! ➡️ https://lnkd.in/ehKKrdwU
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
Get directions
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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FDA continues its work on Highly Pathogenic Avian Influenza (HPAI). This week we invited state partners to participate in a new study to help us understand the prevalence of H5N1 in bulk raw cow’s milk received by dairy processing facilities in the U.S. https://lnkd.in/g4cN7BHb
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Today FDA welcomes the 2024/2025 #VQIP participants! The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program that provides expedited review and import entry of human and animal foods into the U.S. for participating importers. https://lnkd.in/ewF8EvXK
Public List of Approved VQIP Importers
fda.gov
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We have good news to share. The processes for Small Business Determination (SBD) requests and medical device Premarket Approval (PMA) applications and PMA Panel-Track Supplements tracking have been streamlined. Our Center for Devices and Radiological Health (CDRH) has updated the Customer Collaboration Portal to enhance functionality and provide a centralized, self-service touchpoint for customers. Using the CDRH Portal, businesses can submit SBD requests online. In addition, PMA applications and PMA Panel-Track supplements can now be tracked online. Learn more: https://lnkd.in/edNYCrAY
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BREAKING NEWS: 🎉 The FDA has now approved 60 #biosimilars, broadening treatment options for conditions like #diabetes, #arthritis, and #ibd. As healthcare providers, it's crucial to stay informed about these safe and effective alternatives to reference products. Search the FDA's Purple Book to see if there are approved biosimilars that could benefit the conditions you treat and to learn more about biosimilars: https://bit.ly/3WZioLS
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Check out the recently published Office of Medical Policy (OMP) 2023 Annual Report, which highlights the office’s work and the importance of collaboration across CDER and the other centers around the agency: https://lnkd.in/e7NRYddP In 2023, OMP continued to advance cross-cutting policy priorities, including the use of real-world evidence and artificial intelligence in regulatory decision-making. They also continued to develop policies and publications to inform the use of innovative trial design, such as decentralized clinical trials and fit-for-use digital health technologies. In addition, they advanced regulatory policies and activities promoting efficiency, innovation, and transparency across the medical product lifecycle and made significant strides in addressing misinformation and disinformation. Read the annual report to learn more!
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FDA determined the shortage of tirzepatide injection, a GLP-1 medication, has been resolved and reminds compounders of the legal restrictions on making copies of FDA-approved drugs: https://lnkd.in/erxn6Swa Tirzepatide injection has been in shortage since 2022 due to increased demand. FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.
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FDA announced over $5.4 million in new funding to support clinical research for rare neurodegenerative diseases: https://lnkd.in/eFax7JpA
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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
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