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…
Acting FDA Commissioner Ned Sharpless flagged “significant quality and sterility concerns” surrounding a Melbourne, Florida outsourcing facility on Tuesday, as the agency sought a recall of all sterile products compounded…
The FDA issued a warning letter to OTC drug manufacturer Ningbo Pulisi Daily Chemical Products in Zhejiang, China for testing violations, including failure to fully test products prior to release.…
A federal court in Delaware has denied Baxalta’s request for a new trial in a suit brought by Bayer over patent infringement by Baxalta’s hemophilia A drug Adynovate. Source: Drug…
Florida has submitted a plan to HHS for how the state will import lower-cost prescription drugs from Canada. Source: Drug Industry Daily
The FDA hit OTC drug manufacturer NeoBiotech Global of Auburn, Washington with a Form 483 for operating without a quality control unit and other serious violations. Source: Drug Industry Daily