How does the FDA Amendments Act of 2007 affect University of Utah Investigators?

The FDA has the authority to enforce compliance to these clinical trial registry requirements put forth by the Act. If a sponsor fails to register any trial which meets the eligibility criteria, fails to submit trial results, or submits false data or information, the NIH will post a notice describing the infractions on the registry data bank. The FDA is also authorized to impose monetary penalties for failure to comply with the requirements of the Act. Any person who violates the provisions of the Act will be subject to penalties up to $10,000. After 30 days of notification, uncorrected violations could incur additional $10,000 daily penalties until the violation is corrected.

Please be aware that all correspondence from the University of Utah FDA Clinical Research Compliance Officer should be taken seriously and any issues need to be addressed in a timely manner, to ensure compliance of the ClinicalTrials.gov registry requirements.

Further Information:

FDA Amendments Act of 2007 (FDAAA)

http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf

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