The US Food and Drug Administration (FDA) has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices (GMPs) related to the ...
The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance ...
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...
The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study ...
The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the ...
The warning letter, issued on March 30 following a September 2025 inspection, says the company’s manufacturing practices have ...
From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S.
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 ...
The US FDA has proposed withdrawing Amgen's Tavneos after finding alleged clinical trial data manipulation. Regulators also ...
The FDA’s real-time clinical trial mechanism allows drug sponsors to transmit data immediately to the regulator through the ...
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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