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RegisterSubmission in USA & Canada [Regulatives / Guidelines]
Hi Luvbloom,
Same here, mine was a 3-way oral admin study for a 505(b)2 filing of a once daily ER vs innovator twice daily. We submitted both CAN and US reference data. No issue with TPD in Canada (or USA FDA). Product was approved.
John
❝ I have an experience with one derma product where the clinical studies (PK and PD both) has been done using US innovator product and the same was submitted to Health Canada (along with the tests and data showing that both the reference i.e. US and Canada are same).
❝
❝ After a few basic question on the testing methodology and few suggestions the product got approved!
Same here, mine was a 3-way oral admin study for a 505(b)2 filing of a once daily ER vs innovator twice daily. We submitted both CAN and US reference data. No issue with TPD in Canada (or USA FDA). Product was approved.
John
Complete thread:
- Submission in USA & Canada Compliance 2013-07-05 13:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Canadian reference Helmut 2013-07-05 14:15
- Canadian reference Compliance 2013-07-06 06:32
- Non-Canadian reference Helmut 2013-07-06 15:20
- Non-Canadian reference jag009 2013-07-06 23:29
- Non-Canadian reference Helmut 2013-07-07 13:49
- Non-Canadian reference jag009 2013-07-06 23:29
- Non-Canadian reference Helmut 2013-07-06 15:20
- Canadian reference jag009 2013-07-07 01:26
- North American POVs / posting statistics Helmut 2013-07-07 14:49
- Canadian reference Compliance 2013-07-06 06:32
- Submission in USA & Canada jag009 2013-07-06 23:22
- Submission in USA & Canada luvblooms 2013-07-08 06:06
- Submission in USA & Canada Compliance 2013-07-08 09:01
- Submission in USA & Canadajag009 2013-07-08 15:12
- Submission in USA & Canada luvblooms 2013-07-08 06:06
- Canadian reference Helmut 2013-07-05 14:15
Ing. Helmut Schütz