K&L Gates Triage: Q&A: What Sponsors and Investigators Need to Know about FDA’s ClinicalTrials.gov Reporting Requirements

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K&L Gates LLP

FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On this week’s episode, Lindsey Rogers-Seitz and Kenneth Kennedy discuss the scope of FDA’s clinicaltrials.gov reporting requirements, as well as the penalties responsible parties may face for failing to meet them.

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