FDA

📢 Register now for our free CE webinar on June 18 from 1-2 PM ET, to learn how to use the Orange Book to find therapeutic equivalence, marketing status, patents, & exclusivities information, including a discussion on commonly asked questions. Register➡️ https://lnkd.in/eeFnQuU9

FDA launched the Emerging Drug Safety Technology Program (EDSTP) to foster engagement and mutual learning between industry and FDA on the use of emerging technology tools, such as artificial intelligence (AI), to advance pharmacovigilance: https://lnkd.in/en_Ev2rE

Today, the U.S. Department of Justice (DOJ) and the U.S. End of
Translation Food and Drug Administration (FDA) announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes. https://lnkd.in/d86tqKCp “Enforcement against illegal e-cigarettes is a multi-pronged issue that necessitates a multi-pronged response,” said Dr. Brian King, the Director of FDA’s Center for Tobacco Products. “This ‘All Government’ approach – including the creation of this new Task Force – will bring the collective resources and experience of the federal government to bear on this pressing public health issue.” Along with the FDA and the Justice Department, the task force will bring together multiple law enforcement partners, including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF); the U.S. Marshals Service (USMS); the U.S. Postal Inspection Service (USPIS); and the Federal Trade Commission (FTC) to coordinate and streamline efforts to bring all available criminal and civil tools to bear against the illegal distribution and sale of e-cigarettes responsible for nicotine addiction among American youth. Additional agencies may join the Task Force in the coming weeks and months.

FDA’s Complex Innovative Trial Design (CID) Paired Meeting Program is accepting meeting requests for this quarter until June 30, 2024: https://lnkd.in/gJRBrX72

Treatment of #OUD is most effective when medications are used. Learn how to integrate them into your primary care practice. Learn more at: https://lnkd.in/eaE8DRvf. #PrescribeWithConfidence #MOUDSavesLives #MedEd #recovery

Join FDA's Oncology Center of Excellence for the 9th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop, June 25, 2024, 11 am to 2:30 pm ET. Each year, the COA-CCT workshop provides a forum for multidisciplinary discussions to advance the understanding of regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials. Agenda and session panelist biographies now posted. View event details and register now! https://lnkd.in/e5Zjjr8D #OCEOutcomes24

Happy #WorldFoodSafetyDay2024! 🎉 This year's theme from FAO and World Health Organization is “Food Safety: Prepare for the Unexpected.” Join the FDA on World Food Safety Day as we spread the word about ways to reduce the risks of foodborne illness, aka food poisoning. https://lnkd.in/ebP5CwD FDA is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled.  Remember, food safety is everyone’s business. #foodsafety #worldfoodsafetyday

📣Join FDA and Clinical Trials Transformation Initiative (CTTI) August 6, 2024 (10:00 AM - 5:30 PM EDT) for a free hybrid public workshop on artificial intelligence (AI) in drug and biological product development. AI holds great potential to transform how drugs are developed, manufactured, and utilized. As with any innovation, AI use in drug development creates new and unique challenges that require both careful management and a risk-based regulatory framework that is built on sound regulatory science approaches. This public workshop will explore guiding principles that are being applied by innovators and regulators to promote the responsible use of AI in the development of safe and effective drugs. Register today ➡️ https://lnkd.in/eP99VH_2

Primary care providers: Want to learn more about how you can directly address the opioid epidemic? Find resources about diagnosing opioid use disorder and prescribing life-saving medication to treat it at: https://lnkd.in/efqZRyNj. #PrescribeWithConfidence #MOUDSavesLives #oud #MedEd #recovery

FDA has published a draft guidance for industry describing the processes and practices applicable to our Bioresearch Monitoring (BIMO) program’s inspections of sites and facilities, as conducted in accordance with section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act. Specifically, this draft guidance addresses the following (to the extent not publicly available in FDA guides and manuals): the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct. FDA is issuing this draft guidance to comply with section 3612(b)(2) of the Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted as part of the Consolidated Appropriations Act, 2023. The deadline for submitting comments to the docket is August 5, 2024. https://lnkd.in/eVkEcEsN