US FDA proposes rule for sponsors to report falsified data within 45 days

The US Food and Drug Administration is proposing to amend its regulations to require sponsors to report information pertaining to any individual that has or may have engaged in falsification of data in studies involving human or animal subjects. Such information would need to be reported “promptly”, but no later than 45 calendar days after the sponsor became aware of the information, according to the proposed rule outlined in the 19 February Federal Register¹.