Combination Product Designations At US FDA Need Faster Appeals, Petition Says
No sponsor is named in the citizen petition, but it was filed on behalf of an applicant that has had a designation-decision appeal "under consideration" for 18 months and counting.
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FDA's Jeffrey Shuren and Janet Woodcock tell a Senate committee that the agency is more concerned with implementing combination product provisions from the 21st Century Cures Act than working on a novel review pathway for device/drug combination products.
Brad Thompson says that phone calls used in current informal process help sponsors understand Office of Combination Product’s thinking, and that a formalized process envision in the new draft guidance could make this dialogue more difficult.
Agency will collect qualitative and quantitative data to evaluate pilot's success and refine form usability and format, reviewer assignment and general timeline expectations.