Health care partners Mark Barnes (Boston) and Tom Bulleit, life sciences partner Al Cacozza (Both of Washington, DC) and health care associate David Peloquin (Boston) authored an article titled “National Institutes of Health Issues a Notice of Proposed Rulemaking on Clinical Trials Registration and a Draft Policy on Registration and Reporting of Results for NIH-Funded Clinical Trials” in the Dec. 17 issue of Bloomberg BNA’s Medical Law & Policy Research Report.
The article explores the impact that the expansion of the provisions of the Food and Drug Administration Amendments Act of 2007 will have on the operation and review of clinical trials and details key provisions of the act including data management protocols and the nature of information required to register a new trial in the system.
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