Tag: FDAAA

FDAAA

Regulatory/FDA

FDA Clamps Down on Company for Failing to Submit Clinical Trial Data to ClinicalTrials.gov

FDA Clamps Down on Company for Failing to Submit Clinical Trial Data to ClinicalTrials.gov

May 3, 2021 – Although the Food and Drug Administration (FDA) has issued more than 40 “Pre-Notices of Noncompliance” to companies to encourage voluntarily compliance with a federal requirement to submit all clinical trial data to the ClinicalTrials.gov database, last week the agency issued its first “Notice of Noncompliance” to Acceleron Pharma for not complying […]

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