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Last Updated: October 3, 2026
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This session offered a quality reviewer's perspective on pre- Victoria Keck, MS, VMD, Division of Clinical Review, discusses types of studies impacted by Protect your valuable data with these essential What should quality teams take away from the 2026 PDA/FDA Joint Regulatory Conference? In September's Warning Letter ... This session provided reminders concerning the patent, exclusivity, and legal information that This session discussed the risk-based regulatory review process for the acceptance of Type II secondary DMFs for the adequacy ... Nilufer Tampal, PhD, Acting Deputy Director of the Office of Bioequivalence, discusses the FDA's bioequivalence This session highlighted major deficiencies and other common issues identified during the filing review of The presentation provided an overview on the U.S. FDA Product-Specific Guidance (PSG) program including how and when ...
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