Posts Tagged fda

Drug Safety Tracked Even After Approval, FDA Says

Monday, April 23rd, 2012 | Permalink

In 2008 the FDA also launched Sentinel, a computer tracking system designed to help identify problems with drugs and medical devices already on the market by searching various databases for possible side effects – rather …

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Drug Safety Tracked Even After Approval, FDA Says

MDMA Statement on Proposed Package for Medical Device User Fees

Friday, February 3rd, 2012 | Permalink

Wed, 02/01/2012 FDA WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today regarding the tentative agreement between FDA and industry negotiators on medical device user fees: read more

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MDMA Statement on Proposed Package for Medical Device User Fees

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 …

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