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U.S. Department of Health and Human Services


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Drug Development Tools

·         Qualification Process for Drug Development Tools Guidance

·         Drug Development Tool (DDT): Animal Model Qualification Program

·         Drug Development Tool (DDT): Biomarker Qualification Program

·         Drug Development Tool (DDT): Clinical Outcomes Assessment Program
Please submit comments for any of the guidances posted in the Drug Development Tools website to the Division of Dockets Management (DDM) under Docket FDA-XXXX-X-XXXX-XXXX. For electronic comments refer to the website http://www.regulations.gov OR you can mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please contact the Regulations.gov HelpDesk at 1-877-378-5457 (toll free) for assistance regarding submissions.