Zdrowie i gospodarka · 28.06.2019
Treatment for Heart Failure: Endpoints for Drug Development; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Treatment for Heart Failure: Endpoints for Drug Development." This draft guidance clarifies that an effect on symptoms or physical function, without a favorable effect on survival or hospitalization, can be a basis for approving drugs to treat heart failure. It also provides recommendations to sponsors on the need to assess mortality effects of drugs under development to treat heart failure.