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Medical Devices / Regulatory Affairs

HHS Mandate to Furnish Full Trial Results Backed With Funding Sanctions

Oct. 10, 2016

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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