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RegisterCC for “creative” designs [Design Issues]
posted by Helmut 
– Vienna, Austria, 2014-09-25 15:19 (4288 d 19:14 ago) – Posting: # 13584
Views: 3,864
Hi ElMaestro,
Well, if one wants to proceed with a “creative” design – deviating a lot from the ones suggested in general guidance(s) – CC is not a bad idea (see this post). Would be too bad if you submit the study and the FDA refuses to review it “You should have asked us before!”…
❝ No, controlled correspondence with FDA is a general option and not a requirement unless otherwise explicitly required by the FDA.
Well, if one wants to proceed with a “creative” design – deviating a lot from the ones suggested in general guidance(s) – CC is not a bad idea (see this post). Would be too bad if you submit the study and the FDA refuses to review it “You should have asked us before!”…
—
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)
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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
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view"){kind=small}
Ing. Helmut Schütz