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Dear all,
I heard from a little birdie that the CMDh is looking into the whole incurred sample re-analysis fiasco. Has anyone heard anything new about it?
Also, I don't beleive this was discussed previously, but here's the situation. We have a client who wishes to run a repeat use procedure. As the BE studies for the original procedure are no longer compliant with the new guideline regarding ISR, they are concerned that if they run this repeat use procedure their original MA might be in danger of being revoked because the BE studies in the original precedure are no longer compliant with the current guidelines (ie. they might have to withdraw the product). This makes absolutely no sense to me. To withdraw a product that has already been on the market for a length of time, wouldn't the authorities need some kind of safety concern to do this?
BTW, has anyone heard anything new about the new Modified-release guideling?
Thank you all.
I heard from a little birdie that the CMDh is looking into the whole incurred sample re-analysis fiasco. Has anyone heard anything new about it?
Also, I don't beleive this was discussed previously, but here's the situation. We have a client who wishes to run a repeat use procedure. As the BE studies for the original procedure are no longer compliant with the new guideline regarding ISR, they are concerned that if they run this repeat use procedure their original MA might be in danger of being revoked because the BE studies in the original precedure are no longer compliant with the current guidelines (ie. they might have to withdraw the product). This makes absolutely no sense to me. To withdraw a product that has already been on the market for a length of time, wouldn't the authorities need some kind of safety concern to do this?
BTW, has anyone heard anything new about the new Modified-release guideling?
Thank you all.
Complete thread:
- ISRThe Outlaw Torn 2012-11-29 15:58
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ISR Dr_Dan 2012-11-29 16:30
- ISR The Outlaw Torn 2012-11-30 07:53
- ISR Ohlbe 2012-12-17 22:53
- ISR The Outlaw Torn 2012-12-18 08:09
- 90% CI riddle Helmut 2012-12-18 17:12
- 90% CI riddle The Outlaw Torn 2012-12-19 07:49
- 90% CI riddle Dr_Dan 2012-12-20 09:45
- 90% CI riddle The Outlaw Torn 2012-12-20 11:23
- 90% CI riddle Dr_Dan 2012-12-20 12:58
- 90% CI riddle The Outlaw Torn 2012-12-20 11:23
- 90% CI riddle Dr_Dan 2012-12-20 09:45
- 90% CI riddle The Outlaw Torn 2012-12-19 07:49
- ISR Dr_Dan 2012-11-29 16:30
Ing. Helmut Schütz