FDA Guidances On Actual Use Studies, Switches Will Clarify Agency Processes
This article was originally published in The Tan Sheet
Executive Summary
A guidance on conducting actual use trials for Rx-to-OTC switch candidates is under development, according to FDA Office of New Drugs Director John Jenkins, MD
You may also be interested in...
Medicare HSAs May Compel Drug Industry To Rethink Position On OTCs
The growth of health savings accounts could force pharmaceutical companies to rethink their approach to OTC switches and consumer marketing, medical economist J.D. Kleinke told the Pharmaceutical Research & Manufacturers of America
FDA Office Of New Drug Restructuring To Include OTC Resource Reallocation
FDA's Office of New Drugs restructuring will more efficiently allocate the agency's resources and staff, particularly with respect to OTCs, Director John Jenkins, MD, said
Supplement Labeling Guide Set For Release This Year – FDA Guidance Agenda
FDA has started preliminary work on a Food Registration Implementation guidance, which the agency said is scheduled to come out after the release of its final rule on facility registration