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Last Updated: October 3, 2026
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Bioequivalence Study Considerations for High-Risk Products Dave Coppersmith from the Office of Generic Drug Policy discusses Nilufer Tampal, PhD, Acting Deputy Director of the Office of FDA CDER's Office of Generic Drugs (OGD) provides an overview of the revised draft guidance for industry on ICH Q3E: Guideline for Extractable and Leachables Patricia Parris (Pfizer) ※ Please note that there might be edited parts due to ... "What is a 90% Confidence Interval (90% CI) in This webinar provided an in-depth look into the draft guidance and explain the ICH EWG's current scientific thinking, and provide ... The Link to the Course: upbeatconsult.com/project/cnb/ # In this webinar, we discuss the impact of the new ICH E14 and S7B revisions on the cardiac safety assessment of new compounds ... Mitchell Frost from CDER's Office of Generic Drugs discusses
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