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  4. Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” - 05/02/2023
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Virtual

Event Title
Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”
May 2, 2023

Date:
May 2, 2023
Time:
1:00 PM - 3:30 PM ET

Topic & Presentations

Speakers

Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”

 

Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”

Lei Zhang, PhD
Deputy Director
Office of Research and Standards (ORS) |
Office of Generic Drugs (OGD)

Summary of Major Differences in Recommendations Between Draft M13A and the Draft FDA ANDA BE Guidance (Aug 2021)*

Nilufer Tampal, PhD
Associate Director of Scientific Quality
Office of Bioequivalence (OB) | OGD

Additional Discussion on Selected Topics

Myong-Jin (MJ) Kim, PharmD
Director
Division of Therapeutic Performance II
(DTPII) | ORS | OGD

Q&A Discussion Panel

Above speakers plus the following non-speaker panelists

Robert Lionberger, PhD
Director
ORS | OGD

Partha Roy, PhD
Director
OB | OGD

Ethan Stier, PhD
Associate Director, Lifecycle Management
Immediate Office (IO) | Office of Clinical
Pharmacology (OCP) | Office of Translational
Sciences (OTS)

Stella Grosser, PhD, MS
Director
Division of Biometrics VIII | Office of
Biostatistics | OTS

Dave Coppersmith, JD
Regulatory Counsel
Division of Policy Development (DPD) | Office
of Generic Drug Policy (OGDP) | OGD

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In December 2022, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly endorsed the draft ICH M13A guideline titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” which provides recommendations for conducting bioequivalence (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.

On January 31, 2023, FDA issued a draft guidance for industry titled M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms, and a Federal Register (FR) notice to solicit public comments on M13A on the FDA website. This draft guidance was developed by the ICH M13 Expert Working Group (EWG) and is intended to provide harmonized, global, scientific recommendations for conducting BE studies during both development and post-approval phases that can increase the efficiency of drug development and accelerate the availability of safe and effective orally administered IR solid oral dosage forms.

The comment period will close on April 3, 2023. Please submit comments before April 3 to ensure that the FDA and ICH M13 EWG consider your comments on this draft guidance before they begin work on the final version of the guidance.

This webinar will take an in-depth look into the draft guidance and explain the ICH EWG’s current scientific thinking, and provide clarification on FDA’s planning on the implementation of M13A.

LEARNING OBJECTIVES

  • Provide an overview of the draft guidance
  • Explain ICH EWG ’s current scientific thinking on selected topics
  • Provide clarification on the FDA planning on the implementation of M13A for generic drug applications

INTENDED AUDIENCE

This webinar is for 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.

FDA RESOURCES

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