John, are you there? [Tips / Tricks]

posted by Helmut Homepage – Vienna, Austria, 2013-05-28 16:56 (3957 d 20:51 ago) – Posting: # 10677
Views: 14,230

Hi ElMaestro!

❝ 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.


Interesting. I never came across the term ‘guideline’ with the FDA. Maybe John knows something about it? Barbara Davit mentioned in the BABE-conference in Ljubljana 2010 that according to a verdict of the US High Court FDA’s draft guidances1 are as binding as the final ones.2 :rotfl:

When EMA’s IR guideline was presented Tomas Salmonson explained why they had to change the title from ‘Note for Guidance…’ to ‘Guideline…’. Since when it comes to legal stuff my brain switches off immediately I can’t report the reason.


  1. Contains Nonbinding Recommendations
    This draft guidance, once finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic.
    * It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Office of Generic Drugs.
  2. Contains Nonbinding Recommendations
    This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Office of Generic Drugs.

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