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  4. M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance - 11/21/2024
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Virtual | Virtual

Event Title
M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance
November 21, 2024

Date:
November 21, 2024
Time:
1:00 p.m. - 3:00 p.m. ET

Topics & PresentationsSpeakers
M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance 
Overview of ICH M13 guideline seriesLei Zhang, PhD
Deputy Director
Office of Research and Standards (ORS)
Office of Generic drugs (OGD) | CDER
 
FDA’s M13A Implementation for Generic Drug Applications: PSG Revisions to Align with M13ANilufer Tampal, PhD
Associate Director of Science Quality
Office of Bioequivalence (OB)
OGD | CDER
FDA’s M13A Implementation for Generic Drug Applications: Focus on PSG Revisions (Additional M13A and Other Revisions)Myong-Jin (MJ) Kim, PharmD
Director
Division of Therapeutic Performance II (DTPII)
ORS | OGD | CDER
Panel Discussion

Panel Discussion Moderator:

Sarah A. Ibrahim, PhD
Associate Director for Stakeholder and Global Outreach Engagement
OGD | CDER

Panelists:

Lei Zhang, Nilufer Tampal, Myong-Jin (MJ) Kim,

And

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

Q&A DiscussionAll Presenters and Panelists
Closing RemarksRob Lionberger

AGENDA

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ABOUT THIS EVENT (Hosted by CDER SBIA)

This webinar will provide 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 address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline.

In July 2024, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly adopted the final ICH M13A guideline titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. M13A provides recommendations for conducting BE studies during development and post-approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. In addition, a question-and-answer document was posted to provide additional clarity. On October 30, 2024 the FDA published its final guidance titled M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms.

INTENDED AUDIENCE

  • Members of the generic drug industry, including current and potential applicants who are interested in submitting an application for a generic drug
  • Regulatory reviewers for generic drug development and assessments
  • Consultants focused on bioequivalence, clinical research coordinators, and foreign regulators

OBJECTIVES

  • Provide an overview of the final guideline and major changes from the draft guideline
  • Provide clarifications and explain scientific thinking on selected topics in M13A and the Q&A document
  • Delineate FDA’s implementation of M13A for generic drug applications including product-specific guidance revisions

FDA RESOURCES

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