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Last Updated: October 3, 2026
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This session offered a case study in which the objective was to analyze and categorize the ten most This presentation discussed the role of the Maximum Daily This session examined the most frequently cited microbiology The ICH M13A guideline provides a framework for classifying drug products as high risk or low risk, based on biopharmaceutical ... This session discussed commonly used control strategies in drug applications and inspectional findings for lyophilized drug ... This session provided a quality perspective of CDER-led drug device combination products with a focus on parenteral drug ... This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment ... This presentation focused on strategies to demonstrate bioequivalence of products reformulated due to nitrosamine concerns. The Deputy Director for Science of the Office of Pharmaceutical Quality (OPQ) Dr. Susan Rosencrance delivers the OPQ keynote ...
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