In April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance on data integrity for in vivo bioavailability and bioequivalence studies. This guidance aims to address data integrity issues that have been identified in the past and provides recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical aspects of these studies.
These studies are typically submitted in support of investigational new drug applications, new drug applications, and abbreviated new drug applications. By implementing the recommendations outlined in the FDA’s draft guidance, applicants and testing sites can ensure that the data collected and analyzed in these studies is accurate and reliable. This is crucial for ensuring the safety and efficacy of new drugs being brought to market.
Data integrity is a key component of maintaining the integrity of the drug approval process and ensuring public health and safety. Stakeholders in the healthcare industry should stay informed about this draft guidance to ensure compliance with best practices and regulations. Maintaining data integrity is essential for upholding the highest standards of quality and safety in healthcare.