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The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices?

作者信息

Rathi Vinay K, Kesselheim Aaron S, Ross Joseph S

机构信息

Yale University School of Medicine, New Haven, Connecticut.

Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

出版信息

JAMA Cardiol. 2016 May 1;1(2):117-8. doi: 10.1001/jamacardio.2016.0002.

DOI:10.1001/jamacardio.2016.0002
PMID:27437879
Abstract
摘要

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