www.fdanews.com/articles/113482-civil-fines-possible-for-fdaaa-violators
Civil Fines Possible for FDAAA Violators
January 6, 2009
Sponsors who do not comply with the clinical trial registration requirements in the FDA Amendments Act of 2007 (FDAAA) are potentially liable to significant civil monetary penalties even though the FDA is probably not actively looking to penalize the unintentionally noncompliant, experts say. “There have not been any clinical trial registration cases as yet, but it’s early,” Daniel Kracov of Arnold & Porter said during a recent FDAnews audioconference. “I think the FDA would rather give a company a chance to cure problems [with registration] unless it sees a deliberate attempt to hide clinical trial information.”
Clinical Trials Advisor
Clinical Trials Advisor