• Skip to main content
  • Skip to main content
Choose which site to search.
University of Arkansas for Medical Sciences Logo University of Arkansas for Medical Sciences
Research and Innovation: Office of Research Compliance
  • UAMS Health
  • Jobs
  • Giving
  • Compliance Education Program
    • Advanced Certified Research Specialist Program
      • Advanced Certified Research Specialist Program Requirements
      • Advanced Certified Research Specialist Registration
    • Certified Research Specialist Program
      • Bonny Hope Wallace Award for Excellence in Human Subject Research
      • Certified Research Specialist Program Proficiency Exam
      • Certified Research Specialist Program Registration
      • Certified Research Specialist Program Requirements
      • Maintaining Certification
    • Educational Resources
    • Forms
      • General Information About the Certified Research Specialist Program
    • Good Clinical Practice Training
    • HIPAA Training
    • Human Subject Protection Training (CITI)
    • Responsible Conduct of Research Training
    • Upcoming Advanced Certified Research Specialist Courses
    • Upcoming Certified Research Specialist Courses
  • Resources and Tools
    • Non-Human Research Use of DEA Controlled Substances
    • Setting Up Studies and/or Research Staff
      • Human Subject Protection Training (CITI)
    • Tools and Templates
      • Regulatory Binders
      • Subject Study File and Source Documentation
  • Compliance Reviews
    • New Investigation Consult and Education Reviews
    • Selection for Review
    • The Review Process
  • Reporting Research Concerns
    • Compliance Hotline FAQs
    • Research Misconduct
  • News
  • Contact Us
  • Helpful Links
  1. University of Arkansas for Medical Sciences
  2. Research and Innovation
  3. Office of Research Compliance
  4. News
  5. FDA Threatens First Firm With Fines for Reporting Failure

FDA Threatens First Firm With Fines for Reporting Failure

After issuing a warning letter nearly a year ago for failure to post required summary trial results on ClinicalTrials.gov, the Food and Drug Administration (FDA) has given Cambridge, Massachusetts-based Acceleron Pharma Inc. a month to submit data from a Phase 2 trial of medications for the treatment of advanced renal cancer or it will face sanctions, including fines. This is the first time FDA has taken action against a firm for noncompliance with reporting requirements. According to FDA’s April 27 letter to Acceleron, FDA alerted the firm in July of “potential noncompliance” and requested it “submit all required results information promptly.”

In an April 28 news release, FDA explained that 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.” FDA noted that “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.” Violations are subject to fines of up to $10,000 per day, in addition to other potential “regulatory action, such as injunction and/ or criminal prosecution.” Compliance with the reporting requirements “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,” FDA said. Acceleron has not publicly responded to the notice.

Link to FDA announcement

Link to Noncompliance Notice

Posted by Kimberly Murphy on May 7, 2021

Filed Under: News

University of Arkansas for Medical Sciences LogoUniversity of Arkansas for Medical SciencesUniversity of Arkansas for Medical Sciences
Mailing Address: 4301 West Markham Street, Little Rock, AR 72205
Phone: (501) 686-7000
  • Facebook
  • Twitter
  • Instagram
  • YouTube
  • LinkedIn
  • Pinterest
  • Disclaimer
  • Terms of Use
  • Privacy Statement

© 2025 University of Arkansas for Medical Sciences