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Hi Irukulla,
I agree with Helmut.
Also, I have been told recently that one should distinguish between guidances and guidelines when it comes to FDA. If I got it right, guidelines are law whereas guidance is not although both may be marked with the usual 'contains nonbinding recommendations' or words to that effect.
I tried to search the CFRs and on FDA's homepage if I could find backup for it, but I got nothing so far. It may very well be because I -sailor, simulant but not lawyer- don't know where to look.
I agree with Helmut.
Also, I have been told recently that one should distinguish between guidances and guidelines when it comes to FDA. If I got it right, guidelines are law whereas guidance is not although both may be marked with the usual 'contains nonbinding recommendations' or words to that effect.
I tried to search the CFRs and on FDA's homepage if I could find backup for it, but I got nothing so far. It may very well be because I -sailor, simulant but not lawyer- don't know where to look.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Differences Irukulla Shravan Kumar 2013-05-28 06:00
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Hard and soft law Helmut 2013-05-28 14:22
- DifferencesElMaestro 2013-05-28 14:37
- John, are you there? Helmut 2013-05-28 14:56
- John, are you there? jag009 2013-05-28 21:12
- Guideline # guidance Helmut 2013-05-28 23:27
- Guideline # guidance jag009 2013-05-30 16:08
- As time passes by Helmut 2013-05-30 17:59
- As time passes by jag009 2013-05-31 15:15
- As time passes by Helmut 2013-05-30 17:59
- Guideline # guidance jag009 2013-05-30 16:08
- Guideline # guidance Helmut 2013-05-28 23:27
- John, are you there? jag009 2013-05-28 21:12
- John, are you there? Helmut 2013-05-28 14:56
Ing. Helmut Schütz