From: Tull, Lori
Sent: Thursday, November 01, 2012 10:55 AM
To: 'Donna Regan'
Subject: RE: two items
Safa had two comments for you.
1. You proposed plan for validation of the cord blood collection procedures is an acceptable approach.
2. In our phone conversation on 10/26/12, you confirmed that your HCV testing question was related to the current shortage of --(b)(4)--HCV confirmatory assay and the requirement for a variance request. As we discussed, for HCT/P donors, the results of confirmatory tests would not override the initial positive or reactive screening test results (except for syphilis tests). Therefore, the shortage of the (b)(4)-HCV confirmatory test does not affect the HCT/P donors and a variance is not required. If you are performing the confirmatory test for donor notification or counseling purposes, you should address the situation regarding this shortage in your SOPs and the donor notification letters.
She didn't see a need for a telecon unless you have additional questions.
Lori A. Tull
Regulatory Management Staff
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research
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From: Donna Regan [mailto:email@example.com]
Sent: Thursday, October 25, 2012 2:50 PM
To: Tull, Lori
Subject: two items
Hello Lori –
Attached you’ll find our Collection Validation; please forward for review and comment. As indicated, we will begin this on Nov 13.
As you’re already aware, the -----(b)(4)----- recently announced a modification of their Hepatitis C virus (HCV) Testing Algorithm due to unavailability of test kits. While a variance is required for their transfusion medicine customers engaged in lookback activities, the SLCBB defers products with positive results at any stage and informs donors/OBs of abnormal tests. Aside from modifying the test provided by the vendor as an amendment to our BLA submission, we’re unclear if a variance is required in our setting. We would like to discuss this issue with the agency for further clarification. Please let me know if this is feasible and times that the appropriate party(ies) would be available.
Donna M. Regan, MT(ASCP)SBB
Director, St. Louis Cord Blood Bank & Cellular Therapy Laboratory
@ SSM Cardinal Glennon Children's Medical Center
3662 Park Avenue
St. Louis, MO 63110
office 314 268 2700 ext 6313