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

posted by bebac_fan – US, 2018-05-05 19:08 (2478 d 15:37 ago) – Posting: # 18756
Views: 3,348

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:

UA Flag
Activity
 Admin contact
23,381 posts in 4,914 threads, 1,664 registered users;
42 visitors (0 registered, 42 guests [including 8 identified bots]).
Forum time: 09:46 CET (Europe/Vienna)

Science is built up with facts, as a house is with stones.
But a collection of facts is no more a science
than a heap of stones is a house.    Henri Poincaré

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