US Health & Human Services Gives FDA Authority To Investigate Misleading Clinical Trial Data

In a notice published yesterday in the Federal Register, the Secretary of the U.S. Department of Health and Human Services delegated to the Food and Drug Administration authority “[t]o determine that any clinical trial information was not submitted as required under 42 U.S.C. 282(j) or was submitted but is false or misleading in any particular and to notify the responsible party and give such party an opportunity to remedy non-compliance by submitting required revised clinical trial information not later than 30 days after such notification.” FR Doc. 2012-2359. Context for this decision is provided at FDA Given New Authority to Oversee Clinical Trials Data Reporting, Regulatory Focus (Sept. 25, 2012).

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