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kinlaw

12/29/09 12:21 PM

#7714 RE: kinlaw #7713

Lets take this one step further. If you take a look at the guidance performance for the FDA that is posted on the site, you will see how they have performed in the past few years to meet these guidelines (dates).

After the second or Additional Information request: 60 days

2005 70% received notice by this timeframe
2006 80%
2007 90%
2008 ?
2009 ?
With recent concern of FDA dragging their feet you would think this percentage would get better!
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wizard69

12/29/09 1:51 PM

#7715 RE: kinlaw #7713

Are you saying that dean, the man of many fda approvals, doesn't know what the correct response time is from the fda. This is the guy that touted approval before or during the rsna show, which would have been about 10-14 days after submittal. You also might want to get this info to Mike N. who recently responded to an e-mail from a I-hub poster that the fda always takes its full 30 days when it gives approval.(this info he said from dean, the man of many approvals)