Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

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 ...

The USFDA completed a Pre-Approval Inspection at Enzene Biosciences, Alkem Laboratories’ subsidiary in Chakan, Pune, on 13th ...

Veteran radiopharmaceutical executive joins to accelerate partnerships, regulatory alignment, and scalable growth in ...

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

Alkem Laboratories faced a USFDA pre-approval inspection at its Chakan-based facility of Enzene Biosciences, resulting in a ...

The FDA cracked down on two plants in India and one in Korea in separate recently released reports, citing issues ranging from mold to skirted testing procedures. A Sun Pharma plant in Gujarat, India ...

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 US Food and Drug Administration (US FDA) has completed a current good manufacturing practice (CGMP) inspection at ...

PHILADELPHIA, Nov. 25, 2025 /PRNewswire/ -- Rx-360, the International Pharmaceutical Supply Chain Consortium, is proud to announce a strategic partnership with Leucine, an AI-powered platform ...