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FDA CDER’s Office of Generic Drugs (OGD) provides an overview of the revised draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA).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...

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