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Fourth guidance on clinical outcome assessments in patient-focused development hinges on regulatory use

Under the last iteration of the prescription drug user fee program (PDUFA VI) and the 21st Century Cures Act, the FDA was directed to issue several guidance documents on incorporating Clinical Outcome Assessments into patient-focused drug development methods. The fourth and final of these guidance documents provides recommendations on the regulatory use of COAs both as endpoints and within endpoints.

Background: A series of four COA guidance documents.

According to the FDA, a Clinical Outcome Assessment (COA) is a “measure that describes or reflects how a patient feels, functions or survives.”

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