In a part-draft, part-final guidance issued on Tuesday, the US Food and Drug Administration (FDA) finalized its policy on the quantity of reserve samples to be retained for bioequivalence (BE) and bioavailability (BA) testing to ensure that samples are comparable to reference listed drugs (RLD) and to deter fraud in such testing.
Section IV.B of the guidance, which covers the quantity of the reserve samples to be tested has been issued as a final guidance, and supersedes an August 2020 compliance policy; the remainder of the guidance has been issued in draft form. (RELATED: FDA trims reserve testing quantity requirements, Regulatory Focus 18 August 2020)
The draft portion of the guidance describes how the test and reference drug should be distributed to the testing sites, how testing sites should select samples for testing, which samples should be held in reserve, and how the reserve samples should be retained. It also discusses the roles of each stakeholder in handling and retaining reserve samples…
