Overview of the FDA Product-Specific Guidance Program скачать в хорошем качестве

Overview of the FDA Product-Specific Guidance Program

Christine Le from CDER’s Office of Generic Drugs discusses the product-specific guidance (PSG) development processes including how collaborative efforts on how PSGs are prioritized, developed and published. She also shares PSG webpages including the upcoming PSGs for complex generic drug product development webpage as well as an overview on public requests and bioequivalence (BE) comments. 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 - [email protected]   Phone - (301) 796-6707 I (866) 405-5367