This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. The draft guidance has been left in the original International Council for Harmonization format. The final guidance will be reformatted and edited to conform with FDA’s good guidance practice regulation and style.
Download the Draft Guidance Document
Not for implementation.
Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Read the Federal Register Notice
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