Long awaited, but finally it’s here.
After a long wait, the FDA finalised its guidance on PMTA applications for ENDS and released this to the industry on 11 June 2019.
The guidance sets out a number of non-binding recommendations and states that, ultimately, when the FDA comes to review a PMTA application, decisions will be based on obligations that stem from the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387j).
Take a look at the guidance below:
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