FDA Won’t Require Study Sponsors to Report Suspected Misconduct (1)

Drug and device companies no longer have to worry about getting hit with an FDA enforcement action if they don’t promptly report suspected data fudging in a study they sponsor.

The Food and Drug Administration is withdrawing a proposed rule that would have required sponsors to notify the agency of any information suggesting a clinical researcher falsified data while working on a study to support applications for product marketing approval.
The decision means the medical products industry no longer faces a threat of violating either an FDA law that prohibits the refusal to make reports available or a more general ...