US FDA: Draft on Data Integrity for BE/BA Studies published

Recommendation

7/8 May 2024

Audit Trail Review for Computerised Systems in Analytical Laboratories - Live Online Training

At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies for the submission of INDs (investigational new drug applications), NDAs (new drug applications), ANDAs (abbreviated new drug applications), for the bioanalytical part of clinical studies of BLAs (biologic licence applications) as well as for supplements and variations to these marketing authorisations.

The draft contains the following chapters and subchapters:

I. INTRODUCTION
II. BACKGROUND
III. DISCUSSION
     A. Recommendations for Applicants
         1. Testing Site Selection
         2. Monitoring and Oversight
     B. Recommendations for Testing Site Management
     C. Elements of a Quality Management System 
         1. Data Governance and Data Lifecycle
         2. Records Management
         3. Training
         4. Access and Privileges
         5. Audit Trails
         6. Quality Assurance and Quality Control

Please see the draft as well as the options for commenting the document.