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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 PM - 3:00 PM ET

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.

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
  • Delineate FDA’s planning on the implementation of M13A for generic drug applications
  • Understand the purpose of the accompanying Q&A document
  • Provide clarifications and explain ICH EWG ’s scientific thinking on selected topics

FDA RESOURCES

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

  • RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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