FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

HHS Mandate to Furnish Full Trial Results Backed With Funding Sanctions

Oct. 10, 2016
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The expanded HHS mandate that clinical trial investigators publish their full results on ClinicalTrials.gov is backed up with strong consequences for non-compliance that will be enforced by the FDA and the National Institutes of Health.

Starting in 2017, HHS will require that all clinical trials — even privately funded, industry-sponsored studies and trials that fail to hit their endpoints — must register and publish their results in the public database in a timely manner.

“I’m expecting a flood of trials to get registered,” said FDA Commissioner Robert Califf. — Conor Hale

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