OTRROperational Test Readiness Review
OTRROffice of Therapeutic Research and Review (US FDA)
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When JITC is involved, it will provide input to the OTRR covering interoperability/net-ready aspects of the program based upon pertinent information.
A third and final OTRR will be conducted in July 2005 just prior to the scheduled start time of the LUT.
Address for correspondence: Suzanne Epstein, DCGT, OTRR, CBER, FDA, 1401 Rockville Pike, HFM-521, Rockville, MD 20852-1448, USA; fax: 301-827-0449; e-mail: epsteins@cber.