FDA awards DirectSync Surgical a breakthrough device designation for its patient-powered smart spinal fusion device.
Vanda asks the U.S. Court of Federal Claims to rule that FDA deliberately released confidential commercial information and trade secrets from two Vand...
Federal Register notice: FDA corrects a 4/12 notice about a final guidance entitled A Risk-Based Approach to Monitoring of Clinical Investigations Qu...
Federal Register notice: FDA creates a public docket to collect comments on methodological challenges related to patient experience data associated wi...
Federal Register notice: CDERs Office of Prescription Drug Promotion proposed to conduct a study on Perceptions of Prescription Drug Products with Me...
Federal Register notice: FDA sends OMB an information collection extension entitled Certification of Identity for Freedom of Information Act and Priva...
With the 5/2 posting of five deemed final orders, FDA completes the process of posting 33 deemed final orders that was part of over-the-counter drug m...
FDA issues a partial clinical hold on Sun Pharmas Deuruxolitinib (CTP-543), a JAK inhibitor being evaluated for treating alopecia areata.
