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 ...
FDA issues a guidance on the content and format for some labeling information for breast implants.
FDA releases its latest batch of Warning Letters that include Intrathecal Compounding Specialist and Panacea Biotec.
Federal Register notice: FDA makes available a final guidance entitled Importation of Certain FDA-Approved Human Prescription Drugs, Including Biologi...
FDA places a partial clinical hold on an Inovio planned Phase 2/3 trial of its Covid-19 vaccine candidate INO-4800, including its Cellectra 2000 deliv...