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 US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study ...
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 ...
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 ...
Morning Overview on MSN
FDA says "manipulated" data backed approval, moves to withdraw the drug
The FDA has moved to pull Tavneos (avacopan) from the U.S. market, alleging that manipulated clinical trial data propped up ...
Ramakrishna Sesham, Senior Manager at Astellas Pharma, develops enterprise data governance frameworks that reduce FDA ...
The FDA has issued updated guidance clarifying the use of electronic systems, records, and signatures in clinical investigations, aiming to enhance data integrity, security, and efficiency. The Q&A ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results