DUBLIN--(BUSINESS WIRE)--The "Data Integrity and Document Management Training Course" conference has been added to ResearchAndMarkets.com's offering. Document management and data integrity are a key ...

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 ...

On December 18, 2025, the Food and Drug Administration (FDA) released a final guidance entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The guidance was issued to ...

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued General Correspondence Letters to two third-party testing companies in China after uncovering falsified or otherwise invalid ...

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 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 ...

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by ...

Zydus Lifesciences Limited has informed stock exchanges that the United States Food and Drug Administration (USFDA) has ...

The FDA is stepping up its unannounced inspections of foreign manufacturing facilities. In a statement about the increase in inspections, the Food and Drug Administration did not report how many ...

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 ...