Drugs
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Animal Model Supporting Documents/Templates
- Animal Model Qualification - Letter of Intent (PDF - 39KB)
- Animal Model Qualification - Structure for Initial Briefing Packaging (PDF - 47KB)
- Animal Model Qualification – Structure and Format of Electronic Submissions (PDF - 28KB)
Animal Model Qualification Contacts:
Center for Drug Evaluation and Research (CDER)
Animal Model Qualification Program Team
Email: AnimalModelQualification@fda.hhs.gov
Phone: 301-796-2210
Center for Biologics Evaluation and Research (CBER)
Cynthia Kelley
Email: Cynthia.Kelley@fda.hhs.gov
Phone: 301-827-0636
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