Dihydroergotamine Nasal Spray [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-06-26 10:47  – Posting: # 20363
Views: 1,419

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,

"Pass or fail" (D. Potvin et al., 2008)

Complete thread:

 Admin contact
20,777 posts in 4,351 threads, 1,444 registered users;
online 13 (0 registered, 13 guests [including 9 identified bots]).
Forum time: 05:08 UTC (Europe/Vienna)

All we know about the world teaches us that the effects of A and B
are always different—in some decimal place—for any A and B.
Thus asking “are the effects different?” is foolish.    John W. Tukey

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