Federal Register notice: FDA makes available a draft guide entitled Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Per...
Federal Register notice: FDA makes available a draft guidance entitled Assessment of Pressor Effects of Drugs.
FDA clears a Branchpoint Technologies 510(k) for its Aura ICP Monitoring System, an implantable and wireless intracranial pressure sensor.
Federal Register notice: FDA makes available a guidance entitled Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Mana...
Allergan recalls one lot of oral contraceptive Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg...
FDA issues two draft guidances to help prevent branded drug companies from using shared system REMS negotiations to block generic entry.
FDA commissioner Scott Gottlieb says the agency is looking for additional steps it can take to mitigate the effect of drug shortages and help prevent ...
FDA approves a MicroVention PMA for the LVIS and LVIS Jr. stents for stent-assisted coil embolization of intracranial aneurysms.