OTC Switch For Naloxone Finding Interest Among Sponsors
Now that US FDA is about to complete label comprehension study, sponsors seem more positive about OTC versions of naloxone products.
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Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.
Financial model isn't adequate currently, FDA Commissioner Robert Califf says, and agency may make regulatory changes to motivate sponsors.
In announcing expedited assessments for new naloxone ANDAs, the agency also offers guidance to sponsors of discontinued products considering a return to marketing.