FDA JUST RELEASED :
Handling and Retention
of BA and BE Testing
Samples Guidance for Industry
This guidance is intended to provide recommendations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs), including supplemental applications, and contract research organizations (CROs), regarding the procedures for handling reservesamples from relevant bioavailability (BA) and bioequivalence (BE) studies, as required by §§320.38 and 320.63 (21 CFR 320.38 and 320.63),and recommendations regarding
responsibilities of each party involved in the study pertaining to reserve samples.
The guidance highlights:
(1) How the test article (T) and reference standard (RS) for BA and BE studies should be distributed to the testing sites
(2) How testing sites should randomly select samples for testing and material to maintain as reserve samples
(3) How the reserve samples should be retained.