Non-Complex Drug Products and Product-Specific Guidances скачать в хорошем качестве

Non-Complex Drug Products and Product-Specific Guidances

Myong-Jin Kim from CDER’s Office of Generic Drugs discusses non-complex drug products and GDUFA II commitments of non-complex new chemical entities (NCEs) and the format and content of product-specific guidances (PSGs) of non-complex drug products. She also shares a general framework of how PSGs of non-complex drug products are developed and revised and a recent example of significant PSG revisions. Learn more at https://www.fda.gov/drugs/fda-product... _______________________________  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 - CDERSBIA@fda.hhs.gov   Phone - (301) 796-6707 I (866) 405-5367