Consider 505(b)(2) Pathway [Design Issues]

posted by bebac_fan – US, 2018-05-05 15:08 (1099 d 16:39 ago) – Posting: # 18756
Views: 2,367

I think this would need to go through a NDA/505(b)(2) pathway rather than an ANDA.

In this case, comparative efficacy, rather than BE, will be considered pivotal.

Complete thread:

 Admin contact
21,445 posts in 4,482 threads, 1,510 registered users;
online 15 (0 registered, 15 guests [including 2 identified bots]).
Forum time: Sunday 07:48 UTC (Europe/Vienna)

It is better to know some of the questions
than all of the answers.    James Thurber

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