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RegisterDeviating from a guidance [Design Issues]
posted by Helmut 
– Vienna, Austria, 2024-05-20 09:57 (195 d 13:05 ago) – Posting: # 24004
Views: 2,435
Hi Pharma_88,
if you want to deviate from a guidance, you have to initiate a Controlled Correspondence with the FDA’s OGD giving a justification. ‘Because my client wants it’ will not suffice.
if you want to deviate from a guidance, you have to initiate a Controlled Correspondence with the FDA’s OGD giving a justification. ‘Because my client wants it’ will not suffice.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Single dose PK study on Patients Pharma_88 2024-05-15 05:37 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Single dose PK study on Patients Ohlbe 2024-05-15 09:39
- Single dose PK study on Patients Pharma_88 2024-05-17 10:06
- No, sorry Ohlbe 2024-05-17 13:45
- No, sorry Pharma_88 2024-05-20 06:50
- Deviating from a guidanceHelmut 2024-05-20 07:57
- Deviating from a guidance Pharma_88 2024-05-21 08:32
- No, sorry Ohlbe 2024-05-21 12:41
- Deviating from a guidanceHelmut 2024-05-20 07:57
- No, sorry Pharma_88 2024-05-20 06:50
- No, sorry Ohlbe 2024-05-17 13:45
- Single dose PK study on Patients Pharma_88 2024-05-17 10:06
- Single dose PK study on Patients Ohlbe 2024-05-15 09:39
Ing. Helmut Schütz