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New FDA Guidance on Certificates of Confidentiality

Investigators can request discretionary Certificates of Confidentiality (CoCs) from the U.S. Food and Drug Administration (FDA) for non-federally funded research that is subject to FDA regulations. The FDA recently announced new guidance on Certificates of Confidentiality that explains the Agency’s implementation of discretionary CoCs.

See “Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.”

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