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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 dosage forms. Read More
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 Manufacturing Biopharmaceuticals (NIIMBL) to spur innovation in advanced manufacturing. Read More
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) standard the agency has moved towards to gather more study data. Read More
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. Read More
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 concerns about the firm’s own investigation and when it knew about the data discrepancies. Read More
The FDA issued draft recommendations for drug developers on how to make the best use of the agency’s online database of inactive ingredients. Read More
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 and to expanding its scope. Read More