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Final Rule issued on September 16, 2016 for FDAAA 801 


In September 2016, the U.S. Department of Health and Human Services issued a final rule that clarifies and expands the regulatory requirements and procedures for submitting registration and summary results information of clinical trials on ClinicalTrials.gov, in accordance with FDAAA 801. The final rule is intended to make it clear to sponsors, investigators, and the public which trials must be submitted, when they must be submitted, and whether compliance has been achieved. For example, the final rule clarifies the definition of an Applicable Clinical Trial and provides structured criteria for determining which studies meet the definition. The final rule also expands the FDAAA 801 requirements by requiring the submission of results information for trials of unapproved products. The regulation is effective on January 18, 2017 and responsible parties are expected to be in compliance as of April 18, 2017.


Posted on 10-Oct-16 by Larsen, Abigail
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