Guidance for Industry, Investigators, and Institutional Review Boards:
This guidance represents 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 or Office responsible for this guidance as listed on the title page.
Download FDA document here.