In a first for me, the FDA released a guidance that is part final guidance superseding prior guidance and in part new draft guidance open to comment. For those involved in the manufacturing and testing of Bioavailability and Bioequivalence drug product samples and retained samples who are familiar with the current guidance, I'll leave it to you to sort out the various pieces.
From the guidance:
This guidance is a revision of the final guidance Handling and Retention of BA and BE Testing Samples (May 2004) ("the 2004 Guidance"). This guidance is issued in part as final guidance and in part as draft guidance. Specifically, Section IV.B. of this guidance is issued as final guidance. It revises and supersedes the agency's compliance policy related to the quantity of BA and BE samples retained under § 320.38(c) described in the final guidance Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) (August 2020) ("the 2020 Compliance Policy"), which is hereby withdrawn. Section IV.B also describes the conditions under which the agency generally does not intend to take enforcement action against an applicant or CRO that retains less than the quantity of reserve samples (that is, samples of the T and RS that were used in an in vivo BA or in vivo or in vitro BE study) specified in the regulation. This revised compliance policy is for immediate implementation. It also supersedes statements related to quantity of reserve samples in section IX. Number of Reserve Samples for BA and BE Testing of the draft guidance Nasal Aerosols and Nasal Sprays for Local Action (April 2003).5 This revised compliance policy is applicable to all reserve samples for BA and BE studies held to date, including reserve samples from previously completed BA or BE studies.
The rest of this guidance is issued as draft guidance for public comment purposes only. It discusses additional recommendations around the handling and retention of BA and BE testing samples. When finalized, it will represent the agency's current thinking on this topic.
#FDA #guidance #bioavailability #bioequivalence
https://www.fda.gov/media/71393/download
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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