Dihydroergotamine Nasal Spray [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2019-06-26 12:47 (936 d 04:51 ago) – Posting: # 20363
Views: 2,034

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?

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,829 posts in 4,566 threads, 1,555 registered users;
online 11 (0 registered, 11 guests [including 4 identified bots]).
Forum time: Monday 16:39 CET (Europe/Vienna)

Discovery consists of seeing what everybody has seen
and thinking what nobody has thought.    Albert Szent-Györgyi

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