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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.

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Firms Explore First-In-Class Switches With NSURE Still In Limbo

Firms are moving forward with potential first-in-class switches for chronic conditions, says Concentrics Research CEO Julie Aker. Meanwhile, FDA’s NSURE initiative offers “a lot of opportunity,” but “is still very conceptual,” the agency says.

Firms Explore First-In-Class Switches With NSURE Still In Limbo

Firms are moving forward with potential first-in-class switches for chronic conditions, says Concentrics Research CEO Julie Aker. Meanwhile, FDA’s NSURE initiative offers “a lot of opportunity,” but “is still very conceptual,” the agency says.

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Andrea Leonard-Segal and Melissa Furness talked with “The Tan Sheet” about the evolving opportunities for Rx-to-OTC switch and the significance of recent switches. Leonard-Segal, the former director of FDA’s Division of Nonprescription Clinical Evaluation, and Furness, a former DNCE supervisory consumer safety officer, started a consultancy to offer guidance on OTC switch programs and other regulatory areas.

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