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FDA Safety Act Proposes Fines For Failure To Comply With Drug Safety Office

This article was originally published in The Pink Sheet Daily

Executive Summary

Center for Postmarket Drug Evaluation & Research would be able to levy fines starting at $250,000 for failure to complete postmarketing studies on time and for failure to comply with "corrective actions" under the legislation. FDASA would give the independent drug safety office authority over labeling changes and promotional materials.

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