Medical device maker ev3 Inc. received U.S. Food and Drug Administration clearance to market a new stent product.
St. Paul Business Journal (http://www.bizjournals.com/twincities/stories/2006/03/20/daily2.html)
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FDA Seeks Input on Risk-Benefit Reviews for Weight Loss Devices
The FDA said it “continues to receive a high volume of pre-submissions from industry requesting feedback about the necessary data to support pivotal clinical studies and marketing applications for a wide variety of device designs intended for weight loss.”
Costa Rican OTC Drugmaker Hit for Testing, Stability Program
The company said it would employ a third-party testing laboratory, but it didn’t provide a description of the test it would conduct.
