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NIH Issues Proposed Rule Expanding Clinical Trial ...

Issues Proposed Rule Expanding Clinical Trial Registrationand reporting ObligationsbyAmy K. Dow, Robert E. Wanerman, Daniel G. Gottlieb, Ryan R. Benz, Bonnie , and Shilpa Prem*December 2014On November 21, 2014, the National Institutes of Health ( NIH ) published a notice ofproposed rulemaking regarding requirements for Clinical Trial registration and thereporting of results ( Notice or Proposed Rule ).1 These regulations, onceimplemented, will expand and clarify the registration and results reporting requirementsestablished by Section 801 of the Food and Drug Administration Amendments Act of2007, which added Section 402(j) of the Public Health Service Act ( PHS Act ).2 The Proposed Rule is divided into four subparts. The first, Subpart A, sets forth generalprovisions including the overarching definitions. Subparts B and C outline theregistration requirements and results reporting requirements.

www.ebglaw.com NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations by Amy K. Dow, Robert E. Wanerman, Daniel G. Gottlieb, Ryan R. Benz, Bonnie I.

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