Bioequivalence and Bioavailability Forum

Dear all,

on October 30^th the FDA published its final version of ICH M13A and the respective Q&A document. Trivial changes: Instead of decimal numbering of headings the FDA’s system (I–IV.A–D.1–8.a–e.).

Contrary to the previous announcement only 814 PSGs have been updated. See the full list; unfortunately without links to the PSGs.

There was demanding consensus-building process in the ICH’s M13 Experts Working Group (EWG) for more than five years. The result was:

If a drug product is intended for use in both sexes, the inclusion of male and female subjects in the study should be considered.

THX a lot, that was a step forward from the draft!

However, the FDA didn’t give a shit (excuse my French), ignored that and recommends in updated PSGs still inclusion of both sexes.

Sure, PSGs always overrule a general guidance but the FDA’s attitude is not what I consider \(\small{\color{Red}{\textsf{harmoni}}}\color{Red}{\frac{\textsf{s}}{\textsf{z}}}\small{\color{Red}{\textsf{ation}}}\).
Somehow it’s an insult to people working for and attending the GBHI-conferences and the non- members of the ICH’s M13 EWG. 

---

If you didn’t endure the FDA’s 21 Nov 2024 Webinar: https://sbiaevents.com/files2024/M13A-Webinar-Nov-2024-Slides.pdf

As usual I asked two questions:

1. The recommendation of including both sexes in the PSGs is driven by gender politics rather than science. Why were five years of consensus building in the M13 Expert Working Group ignored?
   
2. M13A recommends C_max and AUC_0-t only. The ANDA guidance requires also AUC_0-inf. Will the IR part of the ANDA guidance be updated accordingly in 2025?

Also as usual my questions were disregared.