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.For more information, please see Qualification Process for Drug Development Tools - Guidance for Industry and FDA Staff.
- Animal Model Qualification - Letter of Intent Outline (PDF - 41KB) (updated 12/2013)
- Animal Model Qualification - Initial Briefing Package Outline (PDF - 36KB) (updated 12/2013)
- Animal Model Qualification - Format of Electronic Submissions (PDF - 25KB) (updated 12/2013)
Animal Model Qualification Contacts:
Center for Drug Evaluation and Research (CDER)
Animal Model Qualification Program Team
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)