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Réglementation et droit · 17/12/19961 min de lecture
Roche Molecular Systems, Inc.; Premarket Approval of Roche Amplicor HIV-1 Monitor Test
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Résumé
The Food and Drug Administration (FDA) is announcing its approval of the application by Roche Molecular Systems, Inc., Somerville, NJ, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Roche Amplicor HIV-1 Monitor Test. After reviewing the recommendation of the Blood Products Advisory Committee (BPAC), FDA's Center for Biologics Evaluation and Research (CBER) notified the applicant, by letter of June 3, 1996, of the approval of the application.
Langue originale de la source: Federal Register — All DocumentsOuvrir le communiqué original →
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