Lexology April 4, 2024
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. While the draft guidance only directly applies to BA/BE studies, sponsors and others involved in clinical trials should consider its applicability to other kinds of studies.
As noted by FDA in the Federal Register notice, the guidance is, in part, a reaction to recent “observed data integrity concerns during the inspection of testing sites, clinical testing sites, and analytical testing sites, and during the assessment of the BA and BE study data submitted in support of applications,” with such concerns impacting “application acceptance for filing, assessment, regulatory actions, and approval...
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