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 Reopens Comment Period for Proposed Rule Regarding Regulation of Fixed-Combination Drugs
On December 23, 2015, the FDA announced a proposed rule regarding the regulation of fixed-combination drugs. In its announcement, FDA proposed that its requirements for prescription fixed-combination...
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...