M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance

This webinar provided an update and overview on the final M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms guideline including major changes from the draft guideline and FDA’s current bioequivalence (BE) guidance, delineate FDA’s planning on the implementation of M13A, and addressed questions and provided clarifications based on questions/comments received during public consultation of the draft guideline. Timestamps 00:45 – Overview of ICH M13 guideline series 25:32 – FDA’s M13A Implementation for Generic Drug Applications: PSG Revisions to Align with M13A 48:36 – FDA’s M13A Implementation for Generic Drug Applications: Focus on PSG Revisions (Additional M13A and Other Revisions) 01:11:00 – Panel Discussion 01:34:24 – Q&A Panel Discussion 01:50:56 – Closing Remarks Speakers | Panelists: Lei Zhang, PhD Deputy Director Office of Research and Standards (ORS) Office of Generic drugs (OGD) | CDER Nilufer Tampal, PhD Associate Director of Science Quality Office of Bioequivalence (OB) OGD | CDER Myong-Jin (MJ) Kim, PharmD Director Division of Therapeutic Performance II (DTPII) ORS | OGD | CDER Sarah A. Ibrahim, PhD Associate Director for Stakeholder and Global Outreach Engagement OGD | CDER Robert Lionberger, PhD Director ORS | OGD | CDER Partha Roy, PhD Director OB | OGD | CDER Dave Coppersmith, JD Regulatory Counsel Division of Policy Development (DPD) Office of Generic Drug Policy (OGDP) OGD | CDER Qi Zhang, PhD Immediate Release Drug Products Team Leader DTPII | ORS | OGD | CDER 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