FDA posts a draft guidance on Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.
Federal Register notice: FDA makes available a draft guidance entitled Opioid Dependence: Developing Depot Buprenorphine Products for Treatment.
FDA clears Viz.ai, Inc.s Viz CTP image processing software to view and analyze functional and dynamic CT perfusion images.
FDA approves a Medtronic PMA for In.Pact Admiral Drug-Coated Balloon to treat long superficial femoral artery lesions up to 360mm in patients with per...
FDA Rejects Pfizer Herceptin BiosimilarFDA has sent Pfizer a complete response letter on its BLA for the companys proposed trastuzumab biosimilar, a c...
Fresenius-Kabi USA begins a mandatory software update field action for the DXT Relay 2.x because of issues identified in the software that cause it to...
FDA Review posts the Warning Letters for the week ending 4/20/2018.