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...

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