Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 – Session 4 and Closing

The Generic Drugs Forum (GDF) is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. This year the GDF presentations will focus on hot topics such as GDUFA III updates, information and technology, and complex generics. Timestamps 04:16 – Overview of CREATES Act and Covered Product Authorizations 23:40 – Considerations for Application Pathway: 505(b)(2) or ANDA 45:48 – Resources Available on the Orange Book Website 59:02 – The Global Generic Drug Supply Chain and Need for International Dialogue 01:12:51 – Quality Management Maturity 01:34:21 – Questions & Panel Discussion Speakers: Sharon Coleman, JD Senior Regulatory Counsel Division of Regulatory Policy II (DRP II) Office of Regulatory Policy (ORP) Center for Drug Evaluation & Research (CDER) | FDA Dave Coppersmith, JD Regulatory Counsel Division of Policy Development (DPD) Office of Generic Drug Policy (OGDP) Office of Generic Drugs (OGD) CDER | FDA Truong Quach, PharmD Acting Team Lead Division of Orange Book Publication and Regulatory Assessment (DOBPRA) OGDP | OGD | CDER | FDA Sarah Ibrahim, PhD Associate Director for Stakeholder and Global Engagement OGD | CDER | FDA Djamila Harouaka, PhD Senior Scientific Advisor Office of Quality Surveillance (OQS) Office of Pharmaceutical Quality (OPQ) CDER | FDA Panelists: Sharon Coleman, David Coppersmith, Truong Quach, Djamila Harouaka, and Andrew Fine, PharmD, BCPS Commander, United States Public Health Service (USPHS) Senior Advisor Division of Clinical Review (DCR) Office of Safety and Clinical Evaluation (OSCE) 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 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