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Sen. Grassley's Proposed Drug Safety Office Would Have Labeling Authority

This article was originally published in The Pink Sheet Daily

Executive Summary

Finance Committee chairman is considering the feasibility of giving an independent drug safety office authority to suspend direct-to-consumer ads and marketing. The senator expects to offer legislation that would create the drug safety office soon, although the timeline may change based upon other legislators' actions.

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

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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