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

 The FDA is holding a webinar on this DRAFT guideline on May 2, 2023 from 1:00 PM - 3:00 PM ET.

Registration is available here.

From the announcement:

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On January 31, 2023, FDA issued a draft guidance for industry titled M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms, and a Federal Register (FR) notice to solicit public comments on M13A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 This draft guidance was developed by the ICH M13 Expert Working Group (EWG) and is intended to provide harmonized, global, scientific recommendations for conducting BE studies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 Please submit comments before April 3 to ensure that the FDA and ICH M13 EWG consider your comments on this draft guidance before they begin work on the final version of the guidance.

This webinar will take an in-depth look into the draft guidance and explain the ICH EWG’s current scientific thinking, and provide clarification on FDA’s planning on the implementation of M13A.

Two things stand out from this announcement: 

1) The FDA is holding a webinar on a draft guideline (Which makes me wonder if they are looking to obtain compliance in advance of the final version)

2) The webinar will be AFTER the comment period closes.  (Does this indicate that they are interested in comments outside the comment period?)