Bioequivalence and Bioavailability Forum

Hi Kim,

❝ Q: Since ICH M13A and FDA requirements are inconsistent, which guidelines need to be followed?

Good question.
The guidance ‘Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA’ of August 2021 deals with both IR and MR. Although it is still a draft, it would be wise to follow it.
On 30 October 2024 the FDA published its final version of M13A. IMHO, it overrules sections dealing with IR products of the 2021 ANDA draft and an update of the ANDA guidance is expected for next year.

From last week’s SBIA webinar: