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Generic Combination Products: Assessment and Regulatory Update (14of16) GDF 2020

Ashish Rastogi and Steven Hertz from the CDER Office of Pharmaceutical Quality (OPQ) discuss combination product assessments for ANDAs and provide a regulatory update. Rastogi’s presentation aims to increase transparency in the regulatory process and help applicants understand FDA’s general expectations while preparing quality related sections of ANDA submission for combination products. Hertz discusses the dynamic global regulatory environment and shares best-practices and lessons learned regarding combination product CGMP and PMSR requirements. 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 and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2020 Playlist:    • 2020 CDER Small Business and Industry...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: [email protected] Phone: (301) 796-6707 I (866) 405-5367