Federal Register notice: FDA announces a 4/19 Peripheral and Central Nervous System Drugs Advisory Committee meeting.
FDA has accepted for filing a Medicines360 sNDA to increase the duration of use to prevent pregnancy of its Liletta hormone-releasing intrauterine sys...
PhRMA strongly opposes and AdvaMed strongly supports an FDA proposal for a devices referencing drugs regulatory pathway.
FDA posts a Web page linking to documents on its efforts to improve the predictability and consistency of the electronic submission process.
FDA clears a NeoTract 510(k) for new indications for the UroLift System to treat an enlarged prostate or benign prostatic hyperplasia.
FDA clears a Corindus Vascular Robotics 510(k) for the CorPath GRX System and its use in peripheral vascular interventions.
FDA says Divinity Products has recalled and destroyed dietary supplements it manufactured and distributed that contain kratom.
Four stakeholders ask for changes to an FDA draft guidance on developing targeted therapies in low-frequency molecular subsets of a disease.