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FDA posts a revised draft guidance on ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applicatio...[ Price : $8.95]
FDA concludes that healthcare provider continuing education can be a useful method for providing continuing education under a risk...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance on Controlled Correspondence Related to Generic Drug Development.[ Price : $8.95]
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 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.