FDA Standard Core Clinical Outcome Assessments and Endpoints


The NHC supports the FDA’s interest in promoting the “development of publicly available, standard core sets of Clinical Outcome Assessment (COA) measures for specific disease indications.” We appreciate the amount of consideration required to develop the RFI’s thought-provoking questions. Our comments in section one offer general recommendations on the RFI, and section two provides specific answers to questions listed in the RFI.

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