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BuyOnDips

07/16/10 11:09 AM

#19952 RE: IMGGorBust #19949

ImggORbust
I have not had a chance to view the Money TV show. Did Dean state what day he sent the package with changes?

Admiral38

07/16/10 11:20 AM

#19955 RE: IMGGorBust #19949

Thanks for that rational update. I hope you are right on all counts. Otherwise this thing begins to look as if it were scripted by the Three Stooges.

docmts2

07/16/10 12:47 PM

#19971 RE: IMGGorBust #19949

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.