John, are you there? [Tips / Tricks]
Hi ElMaestro!
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
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.
❝ 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
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.
- 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This draft guidance, once finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic.* It does not create or confer any rights for or on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.
- 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.
- So it ‘will represent’ FDA’s current thinking ‘once finalized’.
Who’s thinking does a guidance represent now?
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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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
Complete thread:
- Differences Irukulla Shravan Kumar 2013-05-28 06:00
- Hard and soft law Helmut 2013-05-28 14:22
- Differences ElMaestro 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