GDF2025 – D1S01 - Office of Generic Drugs (OGD) Keynote

Welcome to the Generic Drugs Forum, a two-day event focused on facilitating the development and approval of high-quality generic medicines. This forum brought together FDA subject matter experts to provide comprehensive insights into pre-ANDA and ANDA assessment programs and guidance on regulatory processes and best practices. Timestamps 01:11 – Working Together to Increase Access to Generic Drugs 05:00 – State of the Generic drug Program 10:44 – Facilitating Access to Generic Drugs 13:14 – Importance of Data Integrity Speaker: Darby Kozak, PhD Deputy Director Office of Generic Drugs (OGD) 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 2025 Playlist -    • 2025 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