ICH Q11 Q&A - A Supporting Document for the Selection and Justification of Starting Materials

FDA discusses key concepts and clarification for starting materials selection based on ICH Q11 Q&A. Presenter: Anita Tiwari, Division of Lifecycle API Learn more at: https://www.fda.gov/drugs/news-events... --------------------  FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.     Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn:   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected]   Phone - (301) 796-6707 I (866) 405-5367