FDA issues an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by Abiomed that could t...
A regulatory expers says FDAs recent draft guidance on Form-483 responses is signaling tougher expectations for how drug manufacturers respond to insp...
Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in drug development.
React Health recalls certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to undetected oxygen leaks and potentially cause ser...
FDA says a Bolton Medical recall of its RelayPro thoracic stent graft system is Class 1.
FDA publishes for reference only an International Council for Harmonization template on a clinical electronic structured harmonized protocol.
Four stakeholders comment to FDA on ways to increase patient access to nonprescription drugs.
FDA announces a 6/18 advisory committee meeting to review Modernas controversial mRNA-based seasonal influenza vaccine.
