Log in
RegisterEuropean BE study for Canada? [Regulatives / Guidelines]
Hi Dr. Dan,
1) I don't think TPD (Canada) will enforce the blinded issue. We submitted US FDA open-label studies (BE and NDA) for Canadian filing and they were okay.
2) Are the names of the innovator product (Euro and Canada) the same?
John
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
1) I don't think TPD (Canada) will enforce the blinded issue. We submitted US FDA open-label studies (BE and NDA) for Canadian filing and they were okay.
2) Are the names of the innovator product (Euro and Canada) the same?
John
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Complete thread:
- European BE study for Canada? Dr_Dan 2012-05-29 09:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- European BE study for Canada?jag009 2012-05-30 18:13
- European BE study for Canada? Vijaya 2012-06-01 10:44
- European BE study for Canada? Dr_Dan 2012-06-01 12:19
Ing. Helmut Schütz