2004N-0408 - Regulatory Site Visit Training Program
FDA Comment Number : EC5
Submitter : Ms. Catherine Lindgren Date & Time: 10/07/2004 04:10:18
Organization : University of Washington
Category :
Issue Areas/Comments
The NCRR-funded Gene and Cell Therapy Laboratory located at the University of Washington is a GMP-compliant cleanroom facility designed to manufacture cell and/or gene based products for Phase I and Phase II clinical trials. We currently have 2 investigator INDs in place and have begun to treat patients. We would like very much to offer our site for the CBER training program, as we believe that our facility represents a realistic example of those facilities generally available to translational researchers in an academic environment.