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 for handling reserve samples from BA/BE studies. It details the different responsibilities of each party involved in such studies, including sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs), and contract research organizations (CROs)…
