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FDA issues an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by ...[ Price : $8.95]
A regulatory expers says FDAs recent draft guidance on Form-483 responses is signaling tougher expectations for how drug manufactu...[ Price : $8.95]
Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in drug development.[ Price : $8.95]
React Health recalls certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to undetected oxygen leaks and p...[ Price : $8.95]
FDA says a Bolton Medical recall of its RelayPro thoracic stent graft system is Class 1.[ Price : $8.95]
FDA publishes for reference only an International Council for Harmonization template on a clinical electronic structured harmonize...[ Price : $8.95]
Four stakeholders comment to FDA on ways to increase patient access to nonprescription drugs.[ Price : $8.95]
FDA announces a 6/18 advisory committee meeting to review Modernas controversial mRNA-based seasonal influenza vaccine.