Dihydroergotamine Nasal Spray [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-06-26 12:47 (461 d 08:35 ago) – Posting: # 20363
Views: 1,676

Hi all,


» » If it is required, …
»
» It is. If you would deviate from a guidance without a controlled correspondence you risk an RtR.

It would be an interesting lawsuit, if the company gets an RtR for lack of baseline correction and sues the FDA because the formal requirement is meaningless.
Perhaps a case where FDA could hide behind the fact that it is a draft and contains nonbinding recommendations blahblah?

I could be wrong, but...

Best regards,
ElMaestro

R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.

Complete thread:

Activity
 Admin contact
21,086 posts in 4,398 threads, 1,468 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Tuesday 21:23 CEST (Europe/Vienna)

To know the history of science is to recognize the mortality
of any claim to universal truth.    Evelyn Fox Keller

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5