Submission of 'failed' studies [Regulatives / Guidelines]
Dear Ohlbe!
Thanks for the information. I didn't know that!
In those ol' days when faxmachines used fanfold thermoprint paper, I was pretty sure that when I was transmitting a 'not-so-nice' drafted report to the sponsor on their side the fax went straight into a document shredder - and the final report to a filing cabinet in the third basement and never saw daylight again...
P.S.: 75/318/EC, Annex I to 2001/83/EC, Annex I to 2003/63/EC.
❝ Independently of the guideline, for EU submissions Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, requires that all clinical trials conducted on the product be submitted, whether positive or negative.
❝
❝ A lot of fuss has been made about this paragraph in the draft EU guideline. There was nothing new in it: this requirement is in place since at least 1975 (Annex to Directive 75/318/EC).
Thanks for the information. I didn't know that!
In those ol' days when faxmachines used fanfold thermoprint paper, I was pretty sure that when I was transmitting a 'not-so-nice' drafted report to the sponsor on their side the fax went straight into a document shredder - and the final report to a filing cabinet in the third basement and never saw daylight again...
P.S.: 75/318/EC, Annex I to 2001/83/EC, Annex I to 2003/63/EC.
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Science Quotes
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
Complete thread:
- Fed-fasted BE studies using different polymorphs london12 2009-08-25 14:21 [Regulatives / Guidelines]
- Fed-fasted BE studies using different polymorphs Helmut 2009-08-27 00:44
- Fed-fasted BE studies using different polymorphs Ohlbe 2009-08-31 01:34
- Submission of 'failed' studiesHelmut 2009-08-31 15:36
- Submission of 'failed' studies Ohlbe 2009-08-31 23:01
- Submission of 'failed' studiesHelmut 2009-08-31 15:36
- Fed-fasted BE studies using different polymorphs qualityassurance 2023-08-03 10:44
- Fed-fasted BE studies using different polymorphs Ohlbe 2009-08-31 01:34
- Fed-fasted BE studies using different polymorphs Helmut 2009-08-27 00:44