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DewDiligence

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DewDiligence

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Re: dav1234 post# 173856

Thursday, 02/06/2014 3:43:21 PM

Thursday, February 06, 2014 3:43:21 PM

Post# of 257273

…FDA trying to set some kind of record on MNTA mcopax review…

It might not be a record. Teva’s Lovenox ANDA has purportedly been under FDA review for 10 years and 8 months (although it was probably withdrawn some time ago).

…there really needs to be some kind pdufa like timeline for [ANDA reviews]…

There is for newly submitted ANDAs—see the GDUFA regs in #msg-70883351.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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