The World Health Organization (WHO) has released updated guidance for quality management system (QMS) requirements for national inspectorates aimed at aligning its content to international standards, the latest QMS principles…
The FDA cited six manufacturers for a variety of issues, including cross-contamination, complaint handling and quality system failures. Source: Drug GMP Report
Three U.S. drug manufacturers were hit with warning letters over shortcomings encountered at their facilities, including data integrity concerns, improper equipment calibration and unproven water systems. Source: Drug GMP Report
The FDA has updated its guidance on changes to risk evaluation and mitigation strategies (REMS) with new details on submissions. Source: Drug GMP Report
CDER released final guidance on submitting next generation nucleotide sequence (NGS) data to support resistance assessments for antiviral drugs. Source: Drug GMP Report
The clock is ticking on the FDA’s enforcement discretion period for stem cells and other new therapies, and Congress raised concerns and questions with the agency about its plans going…
The FDA has approved new warnings for Xeljanz and Xeljanz XR (tofacitinib), including a boxed warning. The warning of an increased risk of blood clots and death applies to the…
The FDA hit Indoco Remedies with a warning letter for significant CGMP violations related to data integrity following an inspection of its production facility in Goa, India. Source: Drug Industry…
Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.)’s drug pricing package is headed to the Senate floor, following the Senate Finance Committee’s markup and 19-9 approval yesterday. Source: Drug Industry…
After months of criticism of the European Commission for the slow release of guidance on the EU’s new medical device regulations, the Commission released a flurry of documents on the…