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Quality Experts Presents Overview of FDA Guidance on Achieving and Maintaining Data Integrity

May 24, 2024  |  Clarkston quality and compliance expert, Susan Shockey, shares an analysis of what to know for the new FDA guidance on achieving and maintaining data integrity for the clinical, nonclinical, and bioanalytical portions of BA and BE studies. View an excerpt below and the full article here.

Quick Read: FDA’s New Draft Guidance On Data Integrity For In Vivo BA/BE Studies

“The U.S. FDA has long been concerned with integrity of data related to GMP processes and documentation, including data submitted as part of applications for approvals. This focus has recently been extended to specifically address integrity of the data for bioavailability (BA) and bioequivalence (BE) studies submitted as part of applications for approvals in new drug applications and biologic license applications. As a result of this increased focus, the FDA released a draft guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies on April 24, 2024.1 The FDA stated in the federal register announcement2 and in the guidance that they have “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. Data integrity concerns can impact application acceptance for filing, assessment, regulatory actions, and approval as well as post-approval actions, such as therapeutic equivalence ratings.”

Read the Full Outsourced Pharma Article Here

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