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FDA

Spectranetics Corporation, a medical device manufacturer, has agreed to pay the United States $4.9 million in civil damages, as well $100,000 forfeiture to resolve claims against the company, the United States Department of Justice (DOJ) announced December 29, 2009. The claims arise from allegations that the company illegally imported unapproved medical devices and provided them [...]

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Guess What Else is NOT a Top Priority of the FDA?

by Nolan and Auerbach on July 12, 2006

Answer: Monitoring postmarketing study commitments. The FDA lacks an effective system for monitoring postmarketing study commitments.  See the latest OIG Report, dated June 2006.

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