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FDA Commissioner Delegated Authority on Clinical Trial Info

09/26/2012

Federal Register Notice: The HHS secretary has delegated to the FDA commissioner authority to 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 information not later than 30 days after such notification. To view this notice, click here.

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