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
France’s National Agency for Safety of Medicines and Health Products released new cybersecurity recommendations for medical devices designed to minimize the risk of cyber attacks. Source: The GMP Letter
Health Canada has issued new guidance on its premarket requirements for medical device cybersecurity. Source: The GMP Letter
Certain models of Medtronic’s MiniMed insulin pumps have potential cybersecurity risks and should be swapped out for newer models, the FDA advised. Source: The GMP Letter
The FDA rapped five devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes. Source: The GMP Letter
The FDA released draft guidance on the content and formatting of Instructions for Use (IFU) for drug- or biologic-device combinations. Source: The GMP Letter