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Re: IMGGorBust post# 19949

Friday, 07/16/2010 12:47:15 PM

Friday, July 16, 2010 12:47:15 PM

Post# of 59549
So it appears that being on the FDA fast track doesn't mean the FDA puts any real effort into expediting the process and even fast track applications will sit on the self collecting dust for weeks at a time. The fast track program seems to simply mean that minor questions can be asked and answered on a less formal basis (by phone, email, etc...) and that the FDA will try to meet certain internal (imaginary) timelines but these timelines are guidelines only (which they meet 90% of the time)and not written in stone.

The policy sited in bold print above basically isn't worth the paper its printed on, IMHO.