This webinar will provide an in-depth look at the draft ICH M13B guideline titled “Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver” that was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly in March 2025.

The ICH M13B guideline, the second guideline in the M13 guideline series, provides recommendations for obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. This guideline is applicable during both development and post-approval phases of orally administered immediate release (IR) solid dosage forms designed to deliver drugs to the systemic circulation.

On May 31, 2025, FDA issued the draft guidance for industry titled “M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver”, and a Federal Register (FR) notice to solicit public comments on draft M13B guidance 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 This draft guidance was developed by the ICH M13 Expert Working Group (EWG) and is intended to provide harmonized, global, scientific recommendations for conducting BE studies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 first comment period for the draft M13B guidance issued by FDA closed on August 1, 2025. FDA intends to reopen the comment period before the webinar. You can submit comments on this guidance at any time; FDA recommends that you check the docket, and submit comments following this webinar on or before October 15, 2025, to ensure that the FDA and ICH M13 EWG consider your feedback on this draft guidance before they begin work on the final guidance. The comments can also help future implementation of the final guidance.

In this webinar, FDA experts will explain the ICH M13 EWG’s current scientific thinking behind the guideline, highlight the main areas that differ from FDA’s current guidance on selected topics and their impact, and provide clarification and rationale on the recommendations in the draft guideline. The webinar aims to facilitate public comments on the draft guideline.

Learning Objectives:

Provide an overview of the draft ICH M13B guideline
Explain the ICH Expert Working Group’s current scientific thinking behind the guideline
Highlight main areas that differ from FDA’s current guidance on selected topics and their impact
Clarify the rationale for the guideline’s recommendations
Explain the process for submitting public comments on the draft guideline

Intended Audience:

This webinar is for members of the drug industry, including current and potential applicants interested in submitting an application for a generic drug and new drug applicants who are using bioequivalence approaches, regulatory reviewers for generic drug development and assessments, consultants focused on bioequivalence, and clinical research coordinators.

There is no cost to attend, and registration is not required.