GUIDANCE
Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions
ABSTRACT — EDITORS' SUMMARY
This FDA guidance provides nonbinding recommendations on the use of Form FDA 3674 for clinical trial data bank certifications, which are required to accompany certain applications and submissions. It addresses sponsor and investigator obligations related to certification of compliance with clinical trial registration and results reporting requirements.
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SOURCE
PDF · CANONICAL LINK http://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions ↗ RELATED · SAME AUTHORITY