FDA Willing To Meet With Sponsors On Epinephrine Auto-Injector OTC Switch

FDA recently told lawmakers it is willing to meet with sponsors to discuss what might be needed for an epinephrine auto-injector to be switched from prescription to over the counter, but wouldn't say whether it has been approached due to the sensitivities of the approval process. The agency outlined the process for switching a drug from prescription to over-the-counter, and said the most likely path for an epinephrine auto-injector would be a supplement to a New Drug Application (NDA), responding...