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FDA clears a Medacta International 510(k) for its 3DMetal Tibial Cones for knee revision surgery.[ Price : $8.95]
FDA posts a revised draft guidance on ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applicatio...[ Price : $8.95]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Federal Register notice: FDA makes available a draft guidance on Controlled Correspondence Related to Generic Drug Development.[ Price : $8.95]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FDA releases a draft guidance incorporating GDUFA 2 revisions on generic drug development controlled correspondence.