Log in
Register|
Komal D ☆ India, 2011-04-15 14:53 (5555 d 22:28 ago) Posting: # 6906 Views: 3,667 |
|
|
Request to provide guidance for MDI and DPI products requirements for Anvisa, US and EU submission. Regards, Komal |
|
ElMaestro ★★★ Denmark, 2011-04-15 16:33 (5555 d 20:48 ago) @ Komal D Posting: # 6907 Views: 3,007 |
|
|
Hello Komal, For EU there is a guideline from 2009. For US there is no guidance. There is an old draft for nasals which is considered obsolete by many. FDA is working on new guideline but noone really knows when, how and what. Things happen on a case-by-case basis. Note that in EU the submission basis is often article 10.3 (and thus differs from the standard generic way), while in US it may be 505(j) or 505(b)(2). This is field where many try and few succeed. — Pass or fail! ElMaestro |
|
Komal D ☆ India, 2011-04-20 09:52 (5551 d 03:29 ago) @ ElMaestro Posting: # 6925 Views: 2,883 |
|
|
Thanks ElMaestro! |
Ing. Helmut Schütz