The USFDA further highlighted deficiencies in environmental monitoring in manufacturing areas, indicating gaps in ensuring controlled production conditions.

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 ...

What’s been overlooked is that the FDA already has the power to fix this. Without new legislation, pilot programs, or years ...

The EMA has started a review of Amgen Inc.’s Tavneos (avacopan) after questions were raised about the integrity of the data in the Advocate study that the agency assessed when granting approval of the ...

In research, digital images, including gel electrophoresis and Western blot images, are not only illustrations but central evidence of data, which must be verified and reproducible. Peer-reviewed ...