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.
HHS secretary Robert F. Kennedy Jr. faces renewed scrutiny from Senate Democrats for ignoring requests about the role of longtime anti-vaccine activis...
Eli Lilly reports that its investigational obesity drug retatrutide produced weight-loss results approaching those historically associated with bariat...
FDA warns Dr. Sourav Mishra about violations in his conduct of a clinical investigation at the All India Institute of Medical Sciences in Bhubaneswar,...
FDA warns Alexandria, LA-based cardiologist Naseem Jaffrani about his failure to conduct a clinical investigation according to the investigational pla...
