US Governemnt will not appeal the ruling on FDAAA Final Rule – former associate FDA commissioner says
According to Peter Lurie, former associate FDA commissioner and current President of the Center for Science in the Public Interest, the US Government will not appeal the ruling by Judge Naomi Reice Buchwald (Southern District of New York) related to the FDAAA Final Rule.
The ruling holds that Food and Drug Administration (FDA), National Institutes of Health (NIH), and Department of Health and Human Services (HHS) have misinterpreted a 2007 law that requires drug companies, universities, and other sponsors to disclose the results of certain clinical trials of FDA-approved products to the public via the ClinicalTrials.gov website.
The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved.
