GDF 2024 | D1S07 - Overview of the FDA Product-Specific Guidance (PSG) Program скачать в хорошем качестве

GDF 2024 | D1S07 - Overview of the FDA Product-Specific Guidance (PSG) Program

This presentation provided an overview of the FDA Product-Specific Guidance (PSG) Program and explained its background and relationship to the Abbreviated New Drug Application (ANDA) program. The session covered the PSG program structure, GDUFA III commitments, and public comments and requests processes. GDUFA III PSG teleconferences (T-Cons) and PSG meetings were discussed to help stakeholders understand available communication opportunities and program benefits. Timestamps 01:00 – What is a Product-Specific Guidance (PSG)? 02:36 – PSG is an Integral Part of the FDA’s ANDA Program 03:26 – Background on PSGs 04:34 – GDUFA III Commitment on PSG Development 16:57 – PSG T-Cons 17:54 – PSG Meetings Speaker: Joe Kotsybar, PharmD Regulatory Health Project Manager Office of Research and Standards (ORS) Office of Generic Drugs (OGD) Center for Drug Evaluation and Research (CDER) | FDA 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 2024 Playlist -    • 2024 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