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Clinical Trial Disclosure and Data Transparency Conference
Session 3: FDAAA Final Rule: Latest Updates from ClinicalTrials.gov
Robert Paarlberg, MS, MSc
- Paarlberg & Associates LLC, United States
The Final Rule expanding the registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) was published in the Federal Register on September 21, 2016. The Final Rule had an effective date of January 18, 2017 and a compliance date of April 18, 2017. This session will provide the latest update from NLM on the Final Rule including how the new requirements for results reporting.
Learning Objective :
Rebecca Williams, PharmD, MPH
- Acting Director, ClinicalTrials.gov, NCBI
- National Library of Medicine, NIH, United States