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National Institutes of Health Extends Effective Date of sIRB Policy

USA - July 17 2017 Recently, the National Institutes of Health (NIH) extended the effective date of its policy on the use of the single Institutional Review Board (IRB...

Sarah H. Stec.


National Institutes of Health Extends Effective Date of sIRB Policy

USA - July 7 2017 Recently, the National Institutes of Health (“NIH”) extended the effective date of its policy on the use of the single Institutional Review Board...

Sarah H. Stec.


Elephants in the Room: What Is Next for Health Policy?

USA - April 4 2017 No different than several chief executives before him, President Donald Trump began his four-year term with the ambitious goal of overhauling domestic...

Beth L. Goldstein, Katie Novaria, John J. Bartrum, Meg Gilley.


EU in vitro Diagnostic Medical Device Regulation Overview Part 3

European Union - February 7 2017 This publication is the third in a series of three that examines the new European Union (EU) regulations governing Medical Devices and in vitro...

Joachim Heine, Adrian Spooner, Sarah H. Stec, Maren Ebner, Colleen Hermann, Aline Doussin.


OIG Expands Protections Under the Anti-Kickback Safe Harbors and the CMP Exceptions

USA - January 23 2017 On December 7, 2016, the Department of Health and Human Services Office of the Inspector General (OIG) published a final rule (Final Rule) 1 that...

Adam D. Colvin, Robert D. Nauman, Sarah H. Stec, John Bunch, Steve Nash, Kinal M. Patel, Peter A. Pavarini, Patrick D. Cornelius.