Federal Register notice: FDA makes available a draft guidance for industry entitled Processes and Practices Applicable to Bioresearch Monitoring Inspe...
A United States Pharmacopeia 2023 drug shortage report highlights four factors contributing to a decade-high level of shortages that last longer than ...
An FDA advisory committee unanimously votes to recommend that Covid-19 vaccine makers formulate their upcoming fall shots to provide protection agains...
Amgen announces positive data from its Phase 3 clinical trial (MITIGATE) evaluating the efficacy and safety of Uplizna (inebilizumab-cdon) for treatin...
FDA denies a Nautilus Gloves request that the agency not rescind its 510(k) clearance for nitrile exam gloves and instead allow the company to substit...
Two stakeholders provide comments and questions on the latest FDA draft guidance on developing drugs to treat early Alzheimers disease.
Medtronic recalls (Class 1) five versions of its StealthStation S8 neurological navigation device after customer complaints about a software error.
FDA warns Mississauga, Canada-based Trexo Robotics Holdings about QS issues in its illegal manufacturing and marketing of robotic medical devices.
