Federal Register notice: FDA makes available a draft guidance on Controlled Correspondence Related to Generic Drug Development.
Trevena files an NDA for Olinvo (oliceridine injection) for treating pain.
FDA posts a final guidance on Formal Dispute Resolution: Sponsor Appeals Above the Division Level that provides recommendations for industry and revie...
Federal Register notice: FDA determines that Bayers Revex (nalmefene hydrochloride injection), which is indicated for reversing an opioid overdose, wa...
FDA releases a draft guidance incorporating GDUFA 2 revisions on generic drug development controlled correspondence.
FDA clears an IntraFuse 510(k) for its FlexThread Fibula Pin System that is intended to provide percutaneous fixation of distal fibula fractures, prim...
FDA commissioner Scott Gottlieb says the agency is very interested in exploring using new opioid packaging requirements to help restrict the flow of t...
Federal Register notice: FDA announces the renewal of the Patient Engagement Advisory Committee for an additional two years.