FDA’s Broad Power Can Overcome NSURE Labeling Obstacles – Attorney
This article was originally published in The Tan Sheet
Executive Summary
Attorney Richard Kingham says the agency has authority to require broadly defined labeling for Rx-to-OTC switches, as well as to obligate generics to follow the same measures as innovator products. Consultant George Quesnelle says FDA’s openness to novel switch strategies on a case-by-case basis is key.