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Consumer OTC Drugs

Rx-TO-OTC SWITCHES: ROLE OF FOREIGN DATA IN NDA REVIEWS

This article was originally published in The Tan Sheet

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Executive Summary

Rx-TO-OTC SWITCHES: ROLE OF FOREIGN DATA IN NDA REVIEWS is one of several issues the OTC drug industry is looking to FDA to clarify, Nonprescription Drug Manufacturers Association Senior VP- Science & Technology William Soller, PhD, said at NDMA's annual marketing seminar in New York City on Jan. 12. Soller suggested that it "would be helpful in today's [regulatory] environment in relation to switch decisions" to have a "clearer understanding" of how foreign data will "be utilized by FDA to evaluate switch safety and effectiveness."

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