The Finalized Bioanalytical Method Validation Guidance: What’s New For NDAs and BLAs – June 17, 2019

Dr. Brian Booth from CDER’s Division of Clinical Pharmacology discusses how FDA Center for Drug Evaluation and Research (CDER) reviewers use the 2018 bioanalytical method validation guidance to conduct drug and therapeutic biologics evaluations. Dr. Booth also discusses the changes in the guidance and how those changes impact sponsors, contract research organizations, and academia. Learn more at https://www.fda.gov/drugs/cder-small-....
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