The Association for Accessible Medicines (AAM) said the US Food and Drug Administration (FDA) should ensure alignment between the International Council on Harmonisation’s (ICH) M13A guidance on bioequivalence testing (BE) of new orally administered immediate-release (IR) solid oral drugs and the agency’s numerous product-specific guidances (PSGs).
Not doing so could delay ongoing ANDA development programs and affect pending approvals. If FDA decides to incorporate ICH M13A changes, the agency should “provide a scientific justification for doing so and discuss the change in approach with the applicant.”
The group also sought clarity on other aspects of the ICH guidance, including the study population, sample sizes, comparator and test products, and fasting and fed conditions.
FDA released the guidance for public consultation on 1 February after the draft guidance reached Step 2 of the ICH process last December. (RELATED: ICH releases draft guideline proposing harmonized bioequivalence testing, Regulatory Focus 3 January 2023)…
