FDA in Brief: FDA takes steps to spark development of heart failure drugs | FDA

FDA in Brief: FDA takes steps to spark development of heart failure drugs | FDA

FDA in Brief: FDA takes steps to spark development of heart failure drugs

The draft guidance, Treatment for Heart Failure: Endpoints for Drug Development, when finalized, will describe the agency’s current thinking on efficacy endpoints related to how patients feel and function, noting that evidence of effectivess of a heart failure drug could be based on improvments in symptoms, such as fatigue, and/or function, such as walking. Additionally, the draft guidance describes how to assess hospitalization as a clinical outcome and discusses possible biomarkers and surrogate endpoints. It also highlights several specific areas that are in need of further discussion, for which the FDA is seeking public input.

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