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-specific-guidances-lighting-development-pathway-generic-drugs-05052021-05052021
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/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2021 Playlist – https://youtube.com/playlist?list=PLey4Qe-UxcxYS1MaTusSgyifQDqdeepyD
SBIA LinkedIn – https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources – https://www.fda.gov/cderbsbialearn
Twitter – https://twitter.com/FDA_Drug_Info
Email – CDERSBIA@fda.hhs.gov
Phone – (301) 796-6707 I (866) 405-5367