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Trevena files an NDA for Olinvo (oliceridine injection) for treating pain.[ Price : $8.95]
FDA posts a final guidance on Formal Dispute Resolution: Sponsor Appeals Above the Division Level that provides recommendations fo...[ Price : $8.95]
Federal Register notice: FDA determines that Bayers Revex (nalmefene hydrochloride injection), which is indicated for reversing an...[ Price : $8.95]
FDA releases a draft guidance incorporating GDUFA 2 revisions on generic drug development controlled correspondence.[ Price : $8.95]
FDA clears an IntraFuse 510(k) for its FlexThread Fibula Pin System that is intended to provide percutaneous fixation of distal fi...[ Price : $8.95]
FDA commissioner Scott Gottlieb says the agency is very interested in exploring using new opioid packaging requirements to help re...[ Price : $8.95]
Federal Register notice: FDA announces the renewal of the Patient Engagement Advisory Committee for an additional two years.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for Regulations for In Vivo Radiopharmaceutical...