Extended-Release PSE Points Acura At First Tamper-Resistant Formulation NDA
This article was originally published in The Tan Sheet
Executive Summary
Like extended-release PSE products already available OTC, a product with tamper-resistant formulation labeling must go through the NDA process. “The novelty of this to the FDA is what testing you do to demonstrate meth resistance … what labeling do you put on a product?” says Acura CEO Bob Jones.
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