Bioequivalence and Bioavailability Forum • Differences

Differences [Tips / Tricks]

posted by ElMaestro – Denmark, 2013-05-28 16:37 (3979 d 18:47 ago) – Posting: # 10676
Views: 14,236

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.

—
Pass or fail!
ElMaestro

Complete thread:

Differences Irukulla Shravan Kumar 2013-05-28 06:00
- 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