![]() ![]() List the brand and generic name of approved drugs, date of approval for NME labeling and the most recent approval date for efficacy supplements. Tools listed in Column 3 were found in labeling for all drugs listed in Column 5, with the exception of those denoted with a superscript COA Type (i.e., a patient-reported outcome, observer-reported outcome, clinician-reported outcome, or performance outcome tool).COA as listed in labeling or the qualification statement.Some of the COAs listed in the COA Compendium may be protected by proprietary rights and, in some cases, a royalty and fee may be charged by the copyright owners for their authorized useĭescribes circumstance under which the COA has been used (i.e., labeled) or has been qualified (for qualified tools under CDER’s DDT Qualification program)ĭescribes the concept that the COA measures ![]() It does not include the endpoint definition of labeled COAs
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