Youtor
>> YOUR LINK HERE: ___ http://youtube.com/watch?v=xv086meWccE
FDA discusses key issues in reviewing first-in-human clinical protocols for cellular and gene therapy products for the treatment of cancer. FDA also shares pitfalls to avoid when describing these studies and lessons learned from successful oncology and gene therapy products. • Presenter: • Peter Bross, MD, Chief (Acting), Oncology Branch, Division of Clinical Evaluation and Pharmacology/Toxicology, Office of Tissues and Advanced Therapies (OTAT), CBER • Learn more at: https://www.fda.gov/drugs/news-events... • -------------------- • FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products clinical research. • Upcoming Training - https://www.fda.gov/cdersbia • SBIA Listserv - https://public.govdelivery.com/accoun... • SBIA 2021 Playlist - • 2021 CDER Small Business and Industry... • SBIA LinkedIn: / cder-small-business-and-industry-assistance • SBIA Training Resources - https://www.fda.gov/cdersbialearn • Twitter - / fda_drug_info • Email - [email protected] • Phone - (301) 796-6707 I (866) 405-5367
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