The October issue of Global Update, a newsletter published by the FDA's Office of Global Policy and Strategy, is now out. Read about the latest on the 19th International Conference of Drug Regulatory Authorities, being held this week, FDA's quality manufacturing and data integrity efforts in India, our first ever food meetings in Colombia, dietary supplements in China – and much more. https://lnkd.in/eCZ_T3ac
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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- Government Administration
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- 10,001+ employees
- Headquarters
- Silver Spring, MD
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- Government Agency
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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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10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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According to newly released data from the 2024 National Youth Tobacco Survey (NYTS), current tobacco product use among U.S. middle and high school students has dropped to the lowest recorded level in 25 years. Within the past year alone, at least half a million fewer students are using tobacco products, contributing to this important progress. Learn more: https://lnkd.in/dvS9-E_s
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FDA issued a final guidance, “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development,” which provides a framework for considering neurodevelopmental evaluations that could be useful to assess long-term safety of a medical product intended for use in newborns: https://lnkd.in/eCFKQXhm
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Looking for information on how to schedule meetings with CBER’s Office of Therapeutic Products (OTP)? Review the “Interactions with OTP” webpage for a list of meeting options – including INTERACT, Type A, pre-IND meetings, and more! https://bit.ly/3B85rbi
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📣Now OPEN!! SBIA’s Annual FDA Clinical Investigator Training Course (CITC) - December 10 -12, 2024. Register early!! ➡️https://lnkd.in/eX7b83PY
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Available now! Recording of the October 10, webinar on Voluntary Sodium Reduction Goals (Edition 2) Draft Guidance and Preliminary Assessment of Progress. The new draft voluntary sodium reduction guidance is part of the White House National Strategy on Hunger, Nutrition, and Health to help reduce diet-related diseases by 2030. https://lnkd.in/eQF3TCTf
Webinar on Voluntary Sodium Reduction Goals
fda.gov
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Learn how FDA researchers studied pH adjustment and addition of antioxidants in tablet formulations using bumetanide to provide potential approaches to drug formulation to mitigate or prevent formation of nitrosamine impurities in the latest Spotlight on CDER Science: https://lnkd.in/enxBBfxY
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Today in New Delhi, India, FDA Deputy Commissioner for Policy, Legislation, and International Affairs Kimberlee Trzeciak delivered the keynote speech at the official opening session of the 19th Annual International Conference of Drug Regulatory Authorities. Regulatory counterparts from about 119 countries were in attendance. At the FDA, “our long-term vision is a global marketplace which consistently offers high-quality medical products …regardless of where they are manufactured or used,” she said, in a speech that focused on the importance of risk mitigation, partnership building, and regulatory harmonization. “Inspecting our way to quality” isn’t feasible, Trzeciak said. “No regulatory authority can do everything on its own. Every member of the supply chain plays a critical role in its success.” Instead, what’s critical is encouraging a culture of quality and developing partnerships that better position the FDA and its counterparts to mitigate the numerous risks that could impact access to high quality medicines and vaccines. Trzeciak concluded by operating strong support for the World Health Organization's new WHO-Listed Authority process, which sets transparent, quantitative, standards for identifying advanced performing regulatory authorities and promotes reliance. This means that regulatory authorities that lack the resources or expertise to perform a function may confidently rely on WLAs for decisions and to guide competency building, which in turn furthers international harmonization, facilitates product access, and enables supply chain integrity, she said. Typically held every two to three years, the ICDRA provides the regulatory authorities of WHO Member States with a forum to promote the exchange of information and collaborative approaches to issues of common concern. This year’s meeting is taking place October 14-18 with the theme of “Smart Regulation: Delivering Quality Assured Medical Products for All.” The conference is hosted by India’s Central Drugs Standard Control Organization and the Ministry of Health and Family Welfare in addition to the WHO. https://lnkd.in/eQFYXJCe
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The FDA will continue to play a central role in ensuring safe, effective, and trustworthy AI tools to improve the lives of patients. Read the JAMA FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine: https://lnkd.in/eXtikgzb
FDA Perspective on the Regulation of AI in Health Care and Biomedicine
jamanetwork.com
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Did you miss #CBEROTP’s September 2024 town hall? Check out the recording to hear #FDA experts answer questions about tissue-engineered products and CMC readiness for #CellTherapy late-stage INDs ➡️ https://bit.ly/4e6ffBx
OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs
fda.gov