Mayne Pharma files an NDA for E4/DRSP (estetrol and drospirenone), an oral contraceptive indicated for preventing pregnancy.
Three healthcare activists say FDA and NIH must start enforcing the FDAAA provision requiring clinical trial data to be submitted to ClinicalTrials.go...
Federal Register notice: FDA submits to OMB an information collection revision entitled Premarket Notification Procedures 21 CFR Part 807, Subpart E....
Federal Register notice: FDA sends to OMB an information collection extension for pediatric- uses of medical devices submissions.
Government and independent sources say FDA accepted a donation of millions of Bayer chloroquine tablets made in facilities in India and Pakistan never...
FDA accepts for priority review a Regeneron Pharmaceuticals BLA for REGN-EB3, an investigational triple antibody cocktail for treating Ebola.
FDA grants an emergency use authorization for Synapse Biomedical and its TransAeris Diaphragmatic Pacing Stimulator System to free up ventilator use.
The ICH says its S11 guideline on safety testing supporting pediatric drug development has reached Step 4 of the approval process.