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CDRH 2012 Strategic Priorities Emphasize QA, Life Cycle Management

Improving premarket programs heads the list

Michael Causey
Mon, 03/05/2012 - 11:50
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Deciphering the Food and Drug Administration (FDA) is a bit like trying to understand what the old USSR was up to during the days of the Cold War. In those days, it was called Kremlinology, or the study of a complex, secretive organization. We need a catchphrase for those who try to figure out what the FDA means when it says something, or what it means when it says nothing, or what it means when it tells you what it means. You get the idea.

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The FDA has been talking a lot of late about transparency. Its Transparency Initiative is an agency attempt, it says, to open up about how it does business. The FDA accepted comments on the initiative until February 28, 2012. The jury is still out on whether this initiative will accomplish much.

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