Abstract
To the Editor: Reporting of aggregate results helps mitigate disclosure biases affecting medical research.1 Although the reporting of summary results is currently mandated by the Food and Drug Administration Amendments Act of 2007 (FDAAA),2 published findings suggest underreporting.3 Two recent proposals are aimed at improving public reporting of aggregate results. These are a Notice of Proposed Rulemaking (NPRM)4 to expand FDAAA requirements to include the results of trials of unapproved products, and a draft policy requiring the results of all National Institutes of Health (NIH)–funded trials, including those not subject to the FDAAA.5 Noncompliance with either requirement would carry a . . .
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
