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Letter to the FDA requesting Takeda immediately cease the dissemination of violative promotional materials for Rozerem

CU hopes that the FDA will support legislation in Congress during the PDUFA user fee debate and the debate on Kennedy-Enzi (S. 484) to add language that will strengthen the requirements for timely, mandatory pre-approval of ads, civil monetary penalties for violations (especially repeat violations), and the more frequent placement of corrective ads so as to prevent abuse.

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