Rx-to-OTC LABEL ACTUAL-USE STUDIES
This article was originally published in The Tan Sheet
Rx-to-OTC LABEL ACTUAL-USE STUDIES should be conducted after all other studies on the drug are completed, FDA Pilot Drug Evaluation and Research Medical Officer Linda Katz, MD, indicated at the Nonprescription Drug Manufacturers Association Research & Scientific Development Conference on Oct. 19. "Labeling needs to be tested," Katz explained, "but it can't be the first thing you do." Labeling usage studies should come "toward the end" of the application review process "when you're coming down to some nuances" on what the label should look like, including "what is more readable" and "which would make the most sense."
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