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  1. Drug Development Tool Qualification Programs

Animal Model Qualification Supporting Documents/Templates

New! Change in Process for Qualification of Drug Development Tools

The process for qualification of drug development tools is changing under new FD&C Act Section 507. FDA is posting information about these updates to the DDT submission processes.

Check for details, documents and information consistent with new section 507(c).

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

NOTE: Please do not send your qualification submissions to the AMQP email account.  This is for inquiries.  For submissions, refer to the document, Format of Electronic Submissions.

Center for Biologics Evaluation and Research (CBER)
Cynthia Kelley
Email:  Cynthia.Kelley@fda.hhs.gov
Phone: 301-827-0636