FDA: antique of ’93 [Regulatives / Guidelines]

posted by jag009  – NJ, 2013-12-12 00:16 (3727 d 16:34 ago) – Posting: # 12041
Views: 10,900

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!


Complete thread:

UA Flag
 Admin contact
22,911 posts in 4,806 threads, 1,635 registered users;
27 visitors (1 registered, 26 guests [including 7 identified bots]).
Forum time: 16:50 CET (Europe/Vienna)

The history of statistics is like a telephone directory:
the plot is boring, full of numbers and the cast is endless.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz