FDA Proposed Rule on Reporting Information on Falsification of Data
This post was written by Paul Sheives.
The Food and Drug Administration (FDA) has published a proposed rule on “Reporting Information Regarding Falsification of Data,” which would require sponsors to self-report any “information indicating that any person has, or may have, engaged in the falsification of data” associated with study results (clinical or pre-clinical) relied upon by the sponsor. Under the new regulations, sponsors would be required to report any such information to FDA as soon as possible, but no later than 45 days after learning of the activity. FDA is accepting comments on the proposed rule until May 20, 2010. For more information, see http://edocket.access.gpo.gov/2010/pdf/2010-3123.pdf
