Generic Drugs Forum 2022 – Day 1, Session 2
FDA presents on the Current State of Generic Drugs and offers practical advice, presenting case studies, and taking a deep dive into the abbreviated new drug application assessment program. Presentations focus on topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs. Includes Q&A session and a moderated panel discussion. 4:54 – ANDA Program Annual Public Stats and What they Mean: Office of Generic Drugs (OGD) 15:49 – ANDA Program Annual Public Stats and What they Mean: Office of Regulatory Operations (ORO) 35:07 - ANDA Program Annual Public Stats and What they Mean: Office of Generic Drug Policy (OGDP) 47:00 - ANDA Program Annual Public Stats and What they Mean: Office of Lifecycle Drug Products (OLDP) 56:22 – Questions & Panel Discussion Presenters and Panel: Iilun Murphy Deputy Director, Clinical & Regulatory Affairs, OGD | CDER Robert Berger - Analytics Team David Holovac - Analytics Team Russell Storms - Associate Director for Analytics Edward (Ted) Sherwood – Director ORO, OGD | CDER Andrew Coogan Lieutenant Commander, U.S. Public Health Service Division of Legal and Regulatory Support (DLRS), OGDP | CDER Derek Smith Deputy Director, OPMA | Office of Pharmaceutical Quality (OPQ) | CDER Geoffrey Wu Commander, U.S. Public Health Service Deputy Director, OLDP | OPQ | CDER For slides and additional information: 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 2022 Playlist - • 2022 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
