@article{42bb6736ff954b2484358b31fae1ef89,
title = "Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products",
author = "Dhruva, {Sanket S.} and Shah, {Nilay D.} and Ross, {Joseph S.}",
note = "Funding Information: Potential Conflicts of Interest: Dr Shah has received research support through Mayo Clinic from the Centers of Medicare and Medicaid Innovation ; from the Agency for Healthcare Research and Quality (R01HS025164 ), R01HS025402 , R03HS025517 , U19HS024075 ); from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) ( R56HL130496 , R01HL131535 ); National Science Foundation ; and from the Patient-Centered Outcomes Research Institute (PCORI). Dr Ross has received research support through Yale University from Johnson and Johnson ; Medtronic , Inc.; the Food and Drug Administration (FDA) ( U01FD004585 ); Blue Cross and Blue Shield Association ; the Centers for Medicare and Medicaid Services (CMS) ( HHSM-500-2013-13018I ); the Agency for Healthcare Research and Quality ( R01HS022882 ); the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) ( R01HS025164 ); and the Laura and John Arnold Foundation . Dr Dhruva reports no competing interests. ",
year = "2020",
month = dec,
doi = "10.1016/j.mayocp.2020.04.013",
language = "English (US)",
volume = "95",
pages = "2609--2611",
journal = "Mayo Clinic proceedings",
issn = "0025-6196",
publisher = "Elsevier Science",
number = "12",
}