Nucleic Acid Testing
This article was originally published in The Gray Sheet
Executive Summary
FDA will accept comments on its draft guidance entitled "Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma" until Jan. 25, 2000 according to a Nov. 26 notice in the Federal Register. The guidance seeks public comment on the development and implementation of nucleic acid testing for infectious agents "when such testing is intended for use in blood donor screening and/or manufacturing of blood products"