September 18, 2001 Companion Approval Letter for Source Plasma - UltraQual HCV RT-PCR Assay
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
September 18, 2001
Our STN: BL 102482/1298
Mr. J. Claude Miller
Senior Vice President
Quality and Regulatory Compliance
Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles, California 90032
Dear Mr. Miller:
Your request to supplement your Biologics License Application (BLA) for human Source Plasma to include the National Genetics Institute UltraQual Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay (UltraQual HCV RT-PCR Assay), when used in combination with FDA approved pooling and resolution algorithms, as indicated for the qualitative detection of hepatitis C virus (HCV) ribonucleic acid (RNA) in pooled human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples, has been approved. The UltraQual HCV RT-PCR Assay will be performed at National Genetics Institute, 2440 S. Sepulveda Boulevard #130, Los Angeles, California 90064.
This information has been placed in your biologics license file. Please keep a copy of this letter available for review at the time of FDA inspections.
--- signature ---
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research