Issue Date: June 28, 2019
Issued by: Center for Biologics Evaluation and Research
Topic(s): Clinical – Medical
Status: Draft
Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry
This guidance has two purposes: 1) to make it clear that an effect on symptoms or physical function, without a favorable effect on survival or risk of hospitalization, can be a basis for approving drugs to treat heart failure; and 2) to provide recommendations to sponsors on the need to assess mortality effects of drugs under development to treat heart failure.
Download the Guidance Document
