The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...
The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
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 ...
In the increasingly complex world of asset management, data integrity is paramount and underpins all facets of operations – from decision-making to regulatory compliance and investor satisfaction. As ...
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