Posts Tagged food

Medical device user fees will be $595M as part of preliminary deal …

Wednesday, February 1st, 2012 | Permalink

User fees have been a bone of contention between the medical device industry and the U.S. Food and Drug Administration, and negotiations have dragged on for a year. Now, a tentative deal has been reached. The FDA announced Wednesday that in exchange for agreeing to shorter review periods for 510(k) applications and other performance improvements, the FDA is getting $595 million over five years from … Comments RSS Post a comment. No comments yet.

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Medical device user fees will be $595M as part of preliminary deal …

Potential of male urinary incontinence treatment in U.S. could be …

Monday, January 2nd, 2012 | Permalink

Uromedica, which develops urinary incontinence treatments, will find out in as soon as a few weeks if its medical device for men is ready for U.S. Food and Drug Administration approval application. The Minnesota medical device company submitted fresh data to the FDA that, if accepted, would be the basis for a premarket approval (PMA) application, CEO Tim Cook said. Uromedica sent the data, which included a … Comments RSS Post a comment. No comments yet.

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Potential of male urinary incontinence treatment in U.S. could be …