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U.S. Dept. of Health & Human Services
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development: Draft Guidance for Industry and FDA Staff
Issued by: Food and Drug Administration (FDA)
DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.
To submit comments on the proposed guidance, visit
Comments close on 1/1/1970
Date Published: 5/29/2020
