After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

Protecting bioanalytical data integrity from bench to report - A Thermo Fisher Scientific White Paper ...

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 ...

Following Viatris’ December announcement that a manufacturing plant in India had been written up by the FDA, a document published by the U.S. regulator reveals the details behind the company's ...

Rx-360 consortium member company employees can visit https://rx-360.org/FDATracker/ to schedule a quick onboarding session ...

City, India, December 23, 2024: In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device manufacturers are enhancing their Good ...

Data integrity is the backbone of every clinical trial, ensuring that research truly benefits patients and advances medical science. When information is accurate, complete, and transparent, doctors ...

FDA is under fire for missing its mandated food safety inspection goals every year since 2018 and for reducing funds for state and local food safety programs The Government Accountability Office ...

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 ...

Indian medical device manufacturers are enhancing their Good Manufacturing Practice (GMP) compliance, reinforcing India's role as a trusted global supplier in the healthcare and MedTech sectors. This ...