M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms

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

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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
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