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...
OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule
Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.
OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule
Financial model isn't adequate currently, FDA Commissioner Robert Califf says, and agency may make regulatory changes to motivate sponsors.
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.