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Sponsors Should Hang Tight On “New Paradigm” Switch – CDER’s Leonard-Segal

This article was originally published in The Tan Sheet

Executive Summary

The director of FDA’s Division of Nonprescription Clinical Evaluation advises firms to wait to submit Rx-to-OTC switch applications until the regulations are revised to allow for expanded conditions of safe nonprescription use.

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Former Division Of Nonprescription Clinical Evaluation Head Leonard-Segal Talks About OTC Switches Past, Present And Future

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.

Former Division Of Nonprescription Clinical Evaluation Head Leonard-Segal Talks About OTC Switches Past, Present And Future

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.

Interview: Leonard-Segal On OTC Switch Past, Present and Future

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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