ONP Has Actual-Use Trial Panel, Rx-To-OTC Switch MaPP In Mind – Ganley
This article was originally published in The Tan Sheet
FDA's Office of Nonprescription Products may examine issues surrounding actual-use trials for OTC drugs at an advisory committee meeting later this year
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Firms submitting switch applications should put more focus on pre-clinical testing, according to Dr. Andrea Leonard-Segal, director of the Division of Nonprescription Clinical Evaluation in FDA's Center for Drug Evaluation and Research