US FDA Has Model Drug Facts Labels For OTC Naloxone, Needs Switch Proposals
Executive Summary
Development of the model DFLs was a first for agency. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.
You may also be interested in...
FDA Stretching Available Funds, Skeleton Workforce In Gov Shutdown Week Three
With no end to the partial shutdown in sight, public safety concerns are mounting along with anxiety among furloughed employees. FDA Commissioner Gottlieb remains a vibrant presence on social media, working to maintain staff morale and reassure the public that critical agency functions carry on.
Shutdown Week Three: Sponsors With Upcoming User Fee Dates Should Start Sweating
US FDA has enough carryover funding for another month of operations, Commissioner Gottlieb says, potentially endangering late February and March review goals.
OTC Switch For Naloxone Finding Interest Among Sponsors
With FDA 'si label comprehension study near completion, sponsors seem more positive about OTC versions of naloxone products. FDA has made clear it is interested in switching the product from Rx-only but had trouble generating sponsor desire to develop it.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: