Intellectual Property Law

New Matter SUMMER 2017 Volume 42, Number 2

Federal Government Expands Public Disclosure Requirements For Clinical Trials: Product Developers Must Publish More Detailed Information, Study Protocols, and the Results of Studies of Unapproved/Unmarketed Products

CHRISTINA M. MARKUS
King & Spalding

BEVERLY H. LORELL, M.D.
King & Spalding

ELAINE H. TSENG
King & Spalding

Pharmaceutical, biological product, and medical device developers must confirm their readiness for the newest stage of clinical trial information disclosure. In response to historical concerns that primarily leading-edge and positive data were being published (while less novel or unfavorable data were sometimes unpublished), federal law since late 2007 has required public registration (i.e., disclosure of the existence, general design, and status of specified clinical trials), and the posting of basic results summaries, in the publicly accessible data bank ClinicalTrials.gov.

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