New HHS clinical trials registry regulations set to go into effect in January 2017: top points in one chart

FDA Alert

28 NOV 2016
By: Gail Hannah Javitt | Jae Kim

Nearly a decade after Congress directed significant expansion of the national clinical trials database, www.ClinicalTrials.gov, the US Department of Health and Human Services (HHS) has issued final implementing regulations (the Final Rule). Weighing in at 177 pages, and informed by nearly 900 comments, the Final Rule, issued in late September, aims to improve public access to information about specified clinical trials involving FDA-regulated products.

Final Rule’s top points

The Final Rule codifies and expands on the requirements specified in the Food and Drug Administration Modernization Act of 1997 FDAAA. The table in the linked report highlights key clarifications and changes. (DLA Piper)