Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Press Announcements

Press Announcements Home
          News & Events
          FDA Newsroom
          Press Announcements
          FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.GovPress Announcements FDA Statement
  FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov

  
  Share
    Post
    Linkedin

    Email
    PrintFor Immediate Release:
                  April 28, 2021
                 
                         Statement From:
         Janet  Woodcock, M.D.
 

  
      
       

  Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise. Across all types of medical product trials, the U.S. Food and Drug Administration works with responsible parties to encourage compliance with the requirements to submit registration and summary results information to the ClinicalTrials.gov data bank, managed by the National Institutes of Health (NIH)/National Library of Medicine.

Sponsors of clinical trials may represent a variety of organizations, including academic institutions, hospitals, private companies and government research organizations, or could be individual researchers. Federal law requires that responsible parties, typically trial sponsors, register applicable clinical trials on ClinicalTrials.gov within 21 days after the first human subject is enrolled and submit certain summary results information for those trials, generally no later than one year after the study’s completion date unless a deadline extension is obtained.

The FDA makes determinations about whether responsible parties are complying with legal requirements for submitting information to ClinicalTrials.gov for applicable clinical trials. These statutory and regulatory requirements are intended to provide greater transparency regarding clinical trials, ultimately allowing the broader scientific community to build on the information submitted. The submission to and posting of clinical trial information on ClinicalTrials.gov honors volunteers who participate in research to advance medical science and enhances public trust by creating a transparent and robust public record of clinical trials and information about their results. When these legal requirements are not met, the FDA has the authority to take enforcement action.

The agency has previously outlined its approach to identifying whether responsible parties have failed to submit required registration and/or summary results information to the ClinicalTrials.gov data bank for applicable clinical trials studying drug products, biological products and device products. Although many responsible parties comply with the law without FDA action, the agency has sent Pre-Notices of Noncompliance (more than 40 to date) to encourage voluntary compliance with the ClinicalTrials.gov requirements.

The FDA has determined that a responsible party who received a Pre-Notice of Noncompliance has not complied with its legal reporting obligations. Accordingly, today, the FDA issued its first Notice of Noncompliance to Acceleron Pharma, Inc. (Acceleron) for failing to submit required summary results information to ClinicalTrials.gov. The company’s applicable clinical trial evaluated the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma. The Notice of Noncompliance gives Acceleron 30 days to submit the required summary results information. The FDA is authorized to seek civil money penalties for Acceleron’s violation, including additional civil money penalties if Acceleron fails to submit the required information within the 30-day period.

The Notice of Noncompliance has also been posted to the FDA’s website and information about the noncompliance will be posted on the study record on ClinicalTrials.gov by NIH. NIH will continue to update the ClinicalTrials.gov records for applicable clinical trials that are the subject of a Notice of Noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed, if any.

The FDA takes its role in enforcing the ClinicalTrials.gov registration and results information submission requirements extremely seriously and we will continue to encourage voluntary compliance with these requirements. When necessary, the FDA will take appropriate actions to help ensure that required information is available on ClinicalTrials.gov as required by law and for the benefit of clinical trial participants and public health.

  Related Information
  
  Related Information
              ClinicalTrials.gov - Notices of Noncompliance and Civil Money Penalty Actions
	FDA’s Role: ClinicalTrials.gov Information
	FDA Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
	Frequently Asked Questions: ClinicalTrials.gov (National Institutes of Health)

###
  Boilerplate
      The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Inquiries
  
    
        
         Media:
                 
      
                            Jeremy Kahn
           
           
                      (301) 796-8671
    Consumer:
                        888-INFO-FDA

                                                                                  Content current as of:
      04/28/2021
               
               
   

        Follow FDA
            Follow @US_FDAon X
                Follow FDAon Facebook
                Follow @FDAMediaon XMore Press Announcements
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop