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“Fast Track” Development and Approval Process for Heart Failure Therapeutics
Author(s) -
Papadimitriou L,
Butler J
Publication year - 2017
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.734
Subject(s) - food and drug administration , fast track , drug development , medicine , drug approval , intensive care medicine , heart failure , process (computing) , drug , risk analysis (engineering) , medical emergency , pharmacology , computer science , surgery , operating system
Heart failure (HF) is a global epidemic, with a high mortality and morbidity burden. In such diseases, earlier access to lifesaving therapeutic regimens is imperative, and could be accomplished by improving the drug development and approval process, without jeopardizing patient safety. The US Food and Drug Administration (FDA) has already established mechanisms facilitating the latter, but further guidance to enhance and expedite the process holds promise to further improve patient outcomes.