FDA warns Indias Panacea Biotec about CGMP violations in its production of finished drugs.
FDA warns Intrathecal Compounding about deficiencies in its production of sterile drugs.
FDA issues a guidance on the content and format for some labeling information for breast implants.
Federal Register notice: FDA announces the availability of a final guidance on Blood Glucose Monitoring Test Systems.
Federal Register notice: FDA makes available a final guidance on assessing Covid19-related symptoms in clinical trials.
Federal Register notice: FDA makes available a final guidance entitled ANDA Submissions Amendments and Requests for Final Approval to Tentatively App...
FDA announces a 10/13 virtual public meeting on Patient-Focused Drug Development for Systemic Sclerosis to obtain patients perspectives on disease imp...
Speaking at a Financial Times conference, FDA commissioner Stephen Hahn says the agency will follow guidelines it has given to industry for approving ...