Study acceptance by US Regulatory [Regulatives / Guidelines]

posted by balakotu – India, 2013-06-19 16:36 (4754 d 11:02 ago) – Posting: # 10819
Views: 3,047

Dear All,

Please clarify regulatory acceptance by US-FDA for a study conducted for Europe region. The reference product is manufatcured in the same facility for both US & Europe and being marketed by the same brand name in both the regulatory regions.

Regards
Kotu

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
155 visitors (0 registered, 155 guests [including 21 identified bots]).
Forum time: 03:38 CEST (Europe/Vienna)

Ignorance more frequently begets confidence
than does knowledge.    Charles Darwin

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