FDA Explains How It Will Pursue Civil Money Penalties for Trial Registration, Result Reporting Violations

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FDA Explains How It Will Pursue Civil Money Penalties for Trial Registration, Result Reporting Violations

J.W. Schomisch

September 20, 2018 at 03:21 PM EST

The FDA released how it will evaluate whether to pursue civil money penalties for violations of ClinicalTrials.gov registration and summary result requirements. “The FDA is responsible for enforcing the clinical trial registration and summary results information submission and certification requirements,” FDA Commissioner Scott Gottlieb said in releasing draft guidance on the... Read More

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FDA Explains How It Will Pursue Civil Money Penalties for Trial Registration, Result Reporting Violations

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