FDA "guidance" represents the current thinking of the Food and Drug Administration on a topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An FDA regulation, on the other hand, carries the weight of law.
FDA issues guidance documents -- ie, publishes them in the Federal Register -- usualy after doing research, which can include holding public hearings.
There may be several phases to issuing or publishing guidance, including:
- Publish Intent in Federal Register
- Although NOT Required, Hold a Public Hearing
- Have a Public Comment Period
- Review Comments Submitted to Docket
- Issue DRAFT Guidance
- Collect & Review Comments on DRAFT Guidance
- Revise DRAFT Guidance Based on Comments, If Necessary and Issue FINAL Guidance
All the above steps are typical of "Level 1" guidances, which discuss changes in interpretation or policy that are
more than of a minor nature, include complex scientific issues, and/or covers highly controversial issues. "Level 2" gudiance, which sets forth existing practices or minor changes in interpretation or policy (e.g., easy to figure out, not controversial). do not need to be issued as a draft for comments/
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