JD Supra

FDA Issues Draft Guidance on Data Integrity Considerations for Bioavailability and Bioequivalence Studies

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...
JD Supra

Keeping Track of Your Data — What You Need to Know about FDA’s Draft Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...
News Medical

The critical role of data integrity in ensuring pharmaceutical quality

The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
Seeking Alpha

BioXcel: Data Integrity Concerns Muddy Regulatory Outlook (Rating Downgrade)

BioXcel Therapeutics faces regulatory challenges after the FDA found inconsistencies in one of its clinical trial sites, jeopardizing the supplementary approval of its drug, IGALMI. BioXcel's ...