FDA Floats OTC Monograph Overhaul To Be “More Agile And Responsive”
This article was originally published in The Rose Sheet
Executive Summary
The agency will conduct a public hearing March 25-26 to garner input on improving the OTC monograph process, which currently faces “significant challenges.” FDA’s proposals include expanding the process for allowing deviations from formulations approved through NDAs and issuing monographs by administrative order.
You may also be interested in...
Reps Prep Sunscreen Filter Legislation; FDA Frustrated By Backlog
Without swift FDA action on eight sunscreen filters pending review, legislators intend to introduce a bill to alter the agency’s sunscreen approval process. House members questioned FDA Center for Drug Evaluation and Research Director Janet Woodcock on the status of the applications, some of which have been under agency review for more than 10 years.
PASS Coalition Works Toward FDA Acceptance Of New(ish) UV Filters
The newly formed Public Access to Sunscreens coalition says it plans to work with FDA, legislators and stakeholders to facilitate review of sunscreen actives. The group proposes user fees as one method of ensuring FDA has the resources it needs to complete sunscreen ingredient evaluations, some of which have been pending as time and extent applications since 2002.
OTC Monographs Face Obsolescence In Shadow Of NDA Products
Many monograph OTCs are overshadowed in the marketplace by NDA products and have much less space on store shelves. With some NDA-approved ingredients moved to monographs, FDA pre-market approval would no longer be required and more firms could make those products.