Debfitech has issued an urgent medical device safety removal letter to its customers of the RMU-2000 ARM XR chest compression device, which provides chest compressions on adults whose hearts suddenly…
Citing ethical and data concerns, four US lawmakers have begun an investigation into clinical research conducted jointly by American biopharma firms and the Chinese military, as well as trials run…
This week, the FDA published final guidance on product-specific guidance meetings between FDA and ANDA applicants and an electronic submission template for medical device de novo requests. Draft guidance was…
In this edition of Quick Notes EU, we note a revised EMA guideline on pharmacovigilance, a call by EMA to revoke authorization of Ocaliva for treatment of primary biliary cholangitis…
Globus Medical, a manufacturer of surgical robots, received an FDA Warning Letter after the company’s inadequate response failed to address findings regarding screws misplaced during surgeries, lack of correction and…
The FDA outlines what goes into a De Novo device request filed using the electronic Submission Template and Resource (eSTAR), in a final guidance released Thursday. Source: Drug Industry Daily
ICU Medical is updating the use instructions for the Plum 360, Plum A+ and Plum A+3 Infusion Systems due to a manufacturing defect of the batteries, which can substantially diminish…
In this edition of Quick Notes, we look at positive news on development of drugs and treatments for multiple myeloma, RSV and follicular lymphoma as well as the discontinuation of…
Drastic changes in drug development mean quality management approaches are more critical than ever, with meaningful advancement hinging on cultural shifts, cross functional alignment and top-down approaches within organizations, as…
The FDA outlined its proposed policy on predetermined change control plans (PCCPs) for medical devices in a new draft guidance. Source: Drug Industry Daily