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Zdrowie i gospodarka · 25/08/2005

FDA Releases Guidance for Industry and Food and Drug Administration Staff on RNA Preanalytical Systems

The Food and Drug Administration (FDA) has released a guidance document outlining the requirements for Ribonucleic Acid (RNA) preanalytical systems used in molecular diagnostic testing, specifically those used in Real Time Polymerase Chain Reaction (RT-PCR). This document is effective immediately and is open to public comment.

Source: Federal Register — Food and Drug AdministrationOpen original release →