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Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA

FDA CDER’s Office of Generic Drugs (OGD) provides an overview of the revised draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA). 00:00 – Welcome 03:06 – Guidance History and Scope 20:30 – Summary of Major Changes in the Aug 2021 Draft ANDA PK BE Guidance 45:55 – Panel Discussion 1:12:45 – Q&A Session 1:53:32 – Closing Remarks FDA SPEAKERS: Lei Zhang, PhD, Deputy Director, Office of Research and Standards (ORS) | OGD | CDER Nilufer Tampal, PhD, Associate Director of Scientific Quality, Office of Bioequivalence (OB) | OGD | CDER FDA PANELISTS: David Coppersmith, Regulatory Counsel, Office of Generic Drug Policy (OGDP) | OGD Myong-Jin Kim, PharmD, Division Director, Division of Therapeutic Performance II (DTP II) | ORS | OGD Bing Li, PhD, Associate Director for Science, OB | OGD Robert Lionberger, PhD, Director, ORS | OGD Diana Vivian, Acting Associate Director, Division of Bioequivalence II (DBII) | OB | OGD Liang Zhao, PhD, Division Director, Division of Quantitative Methods and Modeling (DQMM) | ORS | OGD 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 2022 Playlist -    • 2022 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367