Helmut
★★★
avatar
Homepage
Vienna, Austria,
2018-10-09 16:33
(2403 d 22:02 ago)

Posting: # 19420
Views: 2,882
 

 All animals are equal, but some animals are more equal than others [BE/BA News]

Dear all,

at the BioBridges 2018 Paola Coppola (MHRA, observer at the CHMP’s PKWP) presented a flowchart explaining how a product-specific BE guidance is developed. The devil is in the details. Once the public consultation of the draft is closed, a preliminary version of the final guidance is sent to the originator only (!) to allow for additional comments within ten days.
That’s problematic because these comments are referring to the preliminary version and not the public draft. It also explains some of the published comments which seemingly were out of context.

Attendees of the generic industry were upset and urged to change in this procedure.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,668 registered users;
145 visitors (0 registered, 145 guests [including 8 identified bots]).
Forum time: 14:36 CEST (Europe/Vienna)

Freedom is always and exclusively
freedom for the one
who thinks differently.    Rosa Luxemburg

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