FDA: antique of ’93 [Regulatives / Guidelines]

posted by jag009  – NJ, 2013-12-11 23:16 (3084 d 10:43 ago) – Posting: # 12041
Views: 9,852

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
22,091 posts in 4,630 threads, 1,566 registered users;
online 73 (2 registered, 71 guests [including 66 identified bots]).
Forum time: Monday 10:59 CEST (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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