Two stakeholders provide comments and questions on the latest FDA draft guidance on developing drugs to treat early Alzheimers disease.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.
FDA publishes a draft guidance outlining the standardized format for electronic submission of BLA, NDA, and selected supplements for planning CBER Bio...
Federal Register notice: FDA sends to OMB an information collection extension entitled Prescription Drug Marketing.
Federal Register notice: FDA makes available a draft guidance for industry entitled Processes and Practices Applicable to Bioresearch Monitoring Inspe...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...
