The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and bioequivalence (BE) studies to support ...
The US Food and Drug Administration (FDA) has issued warning letters to a device maker and several drug makers for failing to ...
Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an ...
The Food and Drug Administration's (FDA) drug review arm has proposed withdrawing approval for Amgen Inc.’s AMGN Tavneos (avacopan), citing concerns over data integrity, lack of proven effectiveness, ...
The warning letter, issued on March 30 following a September 2025 inspection, says the company’s manufacturing practices have failed to comply with good manufacturing norms ...
The US FDA has issued an import alert on drugs from Dabur India’s Silvassa plant over data integrity and maintenance lapses, ...
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...
June 11 (Reuters) - The U.S. Food and Drug Administration has issued an import alert for drugs manufactured at Dabur India's ...
The FDA recently announced that it had identified “significant data integrity and study conduct concerns” in various bioequivalence studies conducted by the India-based contract research organization, ...
The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...
Data integrity is an ongoing concern across all R&D organizations, no matter what part of the research lifecycle they’re navigating. These concerns extend beyond the potential for delayed timelines or ...
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