Bioequivalence and Bioavailability Forum 11:19 CET

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FDA: antique of ’93 [Regulatives / Guidelines]

posted by jag009 - NJ, 2013-12-11 23:16  - Posting: # 12041
Views: 4,468

Hi Helmut!

» So far? Unbelievable. Ask your legal department to get refund from the FDA for the study you performed exactly following the guidance only to get from SAS: WARNING: Did not converge...

They don't give refund... The govt just went through "sequester" this year... :-|

Also it was a pilot study.

Strangely, I emailed FDA about stability and they replied back the next day!
Very responsive from that group!

John

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