On September 20, 2024, we posted a blog on the changes that are being contemplated by the FDA with issuance of the final M13A guidance (here). One of the major changes delineated in this guidance was elimination of the previous requirements for fed bioequivalence studies in over 850 different Product Specific Guidances (PSGs) for solid oral dosage forms. In that blog post, I outlined several questions that I hoped the FDA might answer. Well, it looks like the FDA anticipated that implementation might pose a number of such questions and the Agency has announced a two-hour virtual meeting titled “M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms — Implementing the Final Guidance,” which will be held on November 21, 2024, to “address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline.” While the FDA will likely cover the multiple significant changes in the guidance during this meeting, I’m certain that the specific change of dropping fed-study requirements for certain products will play high on the list of interests of participants.
You can register for this virtual meeting here.
The FDA describes the objectives of the meeting as follows:
- Provide an overview of the final guideline and major changes from the draft guideline
- Delineate the FDA’s planning on implementation of M13A for generic drug applications
- Understand the purpose of the accompanying Q&A document
- Provide clarifications and explain the ICH EWG’s (working group’s) scientific thinking on selected topics
I suggest that you and your colleagues set aside time on your calendars for what might be one of the most important and interesting discussions this year!
