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Ultrasound contrast agent reviews should be stayed pending FDA decision on drug/device status -- Bracco.

Executive Summary

ULTRASOUND CONTRAST AGENT NDA/PMA ACTIONS SHOULD BE STAYED until FDA determines whether the agents should be regulated as drugs or devices, Bracco Diagnostics asserts in a Jan. 30 petition filed on behalf of the company by D.C. law firm Kleinfeld, Kaplan & Becker. Bracco requests that FDA "stay any action," including the "review or approval of any pending PMAs or NDAs for ultrasound contrast agents or the convening of an advisory committee meeting on this topic."
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PS029659

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