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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On January 31, 2023, FDA issued a draft guidance for industry titled M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms, and a Federal Register (FR) notice to solicit public comments on M13A on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 This draft guidance was developed by the ICH M13 Expert Working Group (EWG) and is intended to provide harmonized, global, scientific recommendations for conducting BE studies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 Please submit comments before April 3 to ensure that the FDA and ICH M13 EWG consider your comments on this draft guidance before they begin work on the final version of the guidance.

This webinar will take an in-depth look into the draft guidance and explain the ICH EWG’s current scientific thinking, and provide clarification on FDA’s planning on the implementation of M13A.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• Provide an overview of the draft guidance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

FDA SPEAKERS AND PANELISTS

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

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

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

Panel discussion (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

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

• FDA Draft Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms (January 2023)
• ICH M13A Step 2 Presentation (January 2023)
• FDA Draft Guidance: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (August 2021)
• FDA Draft Guidance: Statistical Approaches to Establishing Bioequivalence (December 2022)
• FDA Office of Generic Drugs Global Generic Drug Affairs
• Product-Specific Guidances for Generic Drug Development (main page)

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 webinar 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.
• pre-approved by 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.
• pre-approved by 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
• approved by 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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