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# Key Provisions of ClinicalTrials.gov Final Rule
- URL: https://www.fdaweb.com/key-provisions-of-clinicaltrials-gov-final-rule/
- Published: 2016-11-29T12:00:00.000Z
- Updated: 2026-09-14T21:51:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137445

Attorneys **Gail Javitt** and **Jae Kim** (DLA Piper) say the HHS final rule on expansion of the national clinical trials database (ClinicalTrials.gov) runs 177 pages and aims to improve public access to information about specified clinical trials involving FDA-regulated products. “The final rule both implements and elaborates on the requirements of the 2007 FDA Amendments Act and provides a specific deadline by which ‘responsible parties’ (clinical trial sponsors and investigators) must come into compliance,” the attorneys [write](http://www.lexology.com/library/detail.aspx?g=234265f0-72fd-45e3-bd8e-73ff85c981e7&ref=fdaweb.com). Responsible parties are required to submit additional information when registering, update registration within specified timelines in response to new information, and report on a wider range of adverse events, the online post says. The rule also expands the clinical trial categories for which results must be submitted and specifies penalties for non-compliance, including civil and criminal enforcement action by FDA.

Key clarifications and changes in the final rule are highlighted by Javitt and Kim in a chart.