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The FDA outlined its proposed policy on predetermined change control plans (PCCPs) for medical devices in a new draft guidance.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

This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was…

This edition of Quick Notes features a CRL for Lykos Therapeutics NDA for midomafetamine for treating post-traumatic stress disorder and approvals for Amneal’s Crexont, Novartis’ Fabhalta and Citius Pharmaceuticals’ Lymphir.…

The FDA’s efforts to actively oversee the safety of medical devices after they’ve hit the market have begun to bear fruit, with the agency making strides toward setting up a…

The FTC has submitted a comment supporting the FDA draft guidance on interchangeable biosimilar drugs saying that the recommendations in the guidance would increase patient access to lower-cost prescription medications.…