FDA’s Naloxone Product Approval Standards May See Changes
Executive Summary
Advisory committees will weigh adequacy of current pharmacokinetic requirements and pediatric dosing for novel formulations of the opioid overdose reversal agent.
You may also be interested in...
Complex Generics: Gottlieb Eyes FDA Policy Changes To Speed Approvals
US agency could reconsider requirement that instructions for use be same for branded and generic products, FDA Commissioner-nominee Scott Gottlieb suggests, while also leaving door open to statutory changes in Hatch-Waxman Act.
Complex Generics: Gottlieb Eyes FDA Policy Changes To Speed Approvals
US agency could reconsider requirement that instructions for use be same for branded and generic products, FDA Commissioner-nominee Scott Gottlieb suggests, while also leaving door open to statutory changes in Hatch-Waxman Act.
'Repeal And Replace' Going Relatively Well For Pharma So Far
US White House game plan for repealing and replacing the Affordable Care Act includes a proposal for faster generic drug approvals but no direct government price controls.