FDA Approves New Opioid Despite Controversy
On Friday, November 2nd, FDA announced its approval of Dsuvia™, a highly potent synthetic opioid manufactured by AcelRx Pharmaceuticals, Inc. The drug is a sublingual (under the tongue) formulation...
Opioid Epidemic: FDA “Ups the Ante” on Labeling Requirements for Opioid Painkillers
On Tuesday, March 22 the FDA announced class-wide safety labeling changes for all immediate-release opioid painkillers. FDA stated that these changes are being made as part of the Agency's...
FDA’s Center for Drug Evaluation & Research: 2016 Priorities
FDA’s Center for Drug Evaluation & Research (CDER) 2016 Priorities & Areas of Focus Front Burner Priorities: Negotiate PDUFA 6 agreements Negotiate GDUFA 2 agreements Negotiate a second BSUFA program...