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DewDiligence

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DewDiligence

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Re: jbog post# 208181

Thursday, 01/19/2017 9:39:22 AM

Thursday, January 19, 2017 9:39:22 AM

Post# of 257669
Re: Interchangeable FoBs /indication extrapolation

The FDA has not barred indication extrapolation for interchangeable FoBs, as evidenced by the rejection of ABBV’s Citizen Petition, which is directly on-point (#msg-127947222).

Note that in the write-up you posted, the text about indication extrapolation is not a direct quotation from the guidance document.

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

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