Online pharmacy Valisure petitioned the FDA to recall and suspend the sale of all ranitidine-containing products in the U.S., claiming it found high levels of NDMA across multiple manufacturers and…
An FDAnews analysis of the FDA’s GMP inspection reports for fiscal 2019 shows that drugmakers continue to stumble at the same old hurdles. Source: Drug GMP Report
Following an agency-wide e-mail from the Acting FDA Commissioner marking an increased focus on emerging technologies, the agency has forged a research partnership with the National Institute for Innovation in…
The FDA is planning a small pilot program to test how it handles nonclinical study data submitted electronically in SEND 3.1 format — a Clinical Data Interchange Standards Consortium (CDISC)…
The FDA hit seven drugmakers for quality-related violations, including issues with shared equipment and complaint evaluation. Source: Drug GMP Report
The FDA issued warning letters to four firms for a variety of violations, including testing issues, invalidating out-of-specification test results without justification and the use of untested water in manufacturing.…
Sen. Chuck Grassley (R-Iowa) has urged the FDA to begin inspections of all overseas drug manufacturing facilities without prior notice. Source: Drug GMP Report
A Form 483 issued following an FDA inspection of Novartis subsidiary AveXis’ control testing laboratory — currently the focus of a data manipulation investigation by the agency — is raising…
The FDA issued draft recommendations for drug developers on how to make the best use of the agency’s online database of inactive ingredients. Source: Drug GMP Report
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…