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Bioanalytical Method Validation BMV Panel Discussion – June 17 2019
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Video Source: www.youtube.com/watch?v=lUWfe3AGnWk
An FDA/CDER panel answers audience questions about bioanalytical method validation (BMV). FDA’s 2018 BMV guidance is the official FDA document that conveys the agency’s expectations and recommendations concerning the validation of bioanalytical methods (aka bioassays) supporting regulatory submissions for drugs or biologics. Validation demonstrates that a bioassay can generate reliable data that are used to make or support regulatory decisions concerning safety and/or efficacy. The BMV applies to nonclinical and clinical studies for new or generic drugs, biological drugs, their active metabolites and biomarkers and veterinary applications. Panelists are from CDER’s Office of Generic Drugs (OGD), Office of Clinical Pharmacology (OCP), and the Office of Study Integrity and Surveillance (OSIS). • Find more information at https://www.fda.gov/drugs/cder-small-.... • _______________ • FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products clinical research. • Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities. • Email: [email protected] • Phone: (301) 796-6707 I (866) 405-5367 • LinkedIn: / cder-small-business-and-industry-assistance • Twitter: / fda_drug_info • CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...
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