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RegisterDihydroergotamine Nasal Spray [Regulatives / Guidelines]
Hi all,
» » If it is required, …
»
» It is. If you would deviate from a guidance without a controlled correspondence you risk an RtR.
It would be an interesting lawsuit, if the company gets an RtR for lack of baseline correction and sues the FDA because the formal requirement is meaningless.
Perhaps a case where FDA could hide behind the fact that it is a draft and contains nonbinding recommendations blahblah?
» » If it is required, …
»
» It is. If you would deviate from a guidance without a controlled correspondence you risk an RtR.
It would be an interesting lawsuit, if the company gets an RtR for lack of baseline correction and sues the FDA because the formal requirement is meaningless.
Perhaps a case where FDA could hide behind the fact that it is a draft and contains nonbinding recommendations blahblah?
—
I could be wrong, but...
Best regards,
ElMaestro
"Pass or fail" (D. Potvin et al., 2008)
I could be wrong, but...
Best regards,
ElMaestro
"Pass or fail" (D. Potvin et al., 2008)
Complete thread:
- Baseline sampling NK 2019-06-26 07:25 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dihydroergotamine Nasal Spray Helmut 2019-06-26 10:10
- Dihydroergotamine Nasal SprayElMaestro 2019-06-26 12:47
- Baseline sampling nobody 2019-06-26 10:21
- Dihydroergotamine Nasal Spray Helmut 2019-06-26 10:10
Ing. Helmut Schütz