title: Fostering innovation, advancing patient safety: the kidney health initiative.
abstract: To respond to the serious and underrecognized epidemic of kidney disease in the United States, the US Food and Drug Administration and the American Society of Nephrology have founded the Kidney Health Initiative-a public-private partnership designed to create a collaborative environment in which the US Food and Drug Administration and the greater kidney community can interact to optimize the evaluation of drugs, devices, biologics, and food products. The Kidney Health Initiative will bring together all the necessary stakeholders, including patients, regulators, industry, health care providers, academics, and other governmental agencies, to improve patient safety and foster innovation. This initiative is intended to enable the kidney community as a whole to provide the right drug, device, or biologic for administration to the right patient at the right time by fostering partnerships that will facilitate development and delivery of those products and addressing challenges that currently impede these goals.
authors.affiliation: Center for Drug Evaluation and Research, Office of Medical Policy, US Food and Drug Administration, White Oak, Maryland, USA.
authors.forename: Patrick
authors.initials: P
authors.lastname: Archdeacon
authors.forename: Rachel N
authors.initials: RN
authors.lastname: Shaffer
authors.forename: Wolfgang C
authors.initials: WC
authors.lastname: Winkelmayer
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Falk
authors.forename: Prabir
authors.initials: P
authors.lastname: Roy-Chaudhury
mesh_terms: D023381:Endpoint Determination; D006801:Humans; D062069:Inventions; D007674:Kidney Diseases / Q000628:therapy; D009398:Nephrology / Q000706:statistics & numerical data; D061214:Patient Safety; D055818:Public-Private Sector Partnerships / Q000458:organization & administration*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012955:Societies, Medical; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration