In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often ...

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 ...

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 ...

Opportunities lie in enhancing data integrity auditing skills within pharmaceutical manufacturing, focusing on GxP audits. Companies can capitalize by offering comprehensive training that delves into ...

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 ...

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

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 ...

Opportunities center on delivering comprehensive GCP training that covers recent regulatory updates, the EU Clinical Trials Regulation, and ICH GCP R3. Interactive courses that address new tech in ...

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 ...