US FDA Threatens Fines For ClinicalTrials.gov Noncompliance
Draft guidance states that "responsible parties" could be fined $10,000 for not submitting trial information to the federal data repository as required by law.
You may also be interested in...
Potential fallout from noncompliance goes well beyond regulatory penalties; adherence has improved but less so for smaller companies.
Public scrutiny has made 483 results much more impactful than intended, says Howard Sklamberg, former FDA deputy commissioner for global regulatory operations and policy. He reminds stakeholders that information in them is preliminary.
ClinicalTrials.gov Still Lacks Many Study Results, JAMA Finds; Do Transparency Efforts Need A Boost?
Industry data transparency initiatives are well-established now, but JAMA study suggests holes in efforts to publicly release clinical trial results.