USA – The Association for Accessible Medicines seeks clarity, leeway in BA/BE studies guidance

The Association for Accessible Medicines (AAM) wants the US Food and Drug Administration (FDA) to clarify what its expectations of sponsors of bioavailability (BA) and bioequivalence (BE) studies in the agency’s recently updated guidance on the topic. It also wants regulators to waive a five-year sample retention requirement if the facility has passed agency inspection. FDA published a guidance in March that is mostly in draft form but with a key finalized section that outlines procedures fo...