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.