Single-Donor NAT Filings Should Not Delay Minipool PLAs - Roche, Gen-Probe
This article was originally published in The Gray Sheet
Roche Molecular Systems intends to submit product licensing applications (PLA's) for both minipool and individual donation nucleic acid test (NAT) assays for HCV and HIV in the first quarter of 2000, James Gallarda, PhD, the firm's blood screening program director, said at a Center for Biologics Evaluation and Research-sponsored workshop on the implementation of nucleic acid testing Dec. 14 in Bethesda, Maryland.
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A May 22-25 course to instruct FDA scientific reviewers and field investigators on nucleic acid amplification testing (NAT) technology is one of several FDA/industry co-sponsorship activities planned for upcoming months.
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