Clinical Trials Registration and Results Information Submission; Final Rule

Clinical Trials Registration and Results Information Submission; Final Rule

October 13, 2016, Covington Alert

On September 21, 2016, the National Institutes of Health (NIH) published its final rule, Clinical Trials Registration and Results Information Submission, 42 C.F.R. Part 11. Under Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA), “responsible parties” for specified clinical trials of FDA-regulated drug and device products must submit clinical trial registration information to a publicly available website at www.ClinicalTrials.gov. Responsible parties for specified clinical trials of FDA-approved drug and device products are required to submit clinical trial results information and certain adverse events information to the database as well.