FDA warns Elkhart, Indiana-based Voyant Beauty about CGMP and other violations in its work as a drug contract manufacturer.
FDA says a new draft guidance will help sponsors and investigators broaden and diversify clinical trial participation through using decentralized clin...
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...
