FDA

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

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

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

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

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 Recording of the October 10, webinar on Voluntary Sodium Reduction Goals (Edition 2) Draft Guidance and Preliminary Assessment of Progress.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

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

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

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

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