Zdrowie i gospodarka · 26/11/1999

Draft ``Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma;'' Availability

The Food and Drug Administration (FDA) is issuing a draft guidance document entitled ``Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma.'' The purpose of the draft guidance document is to seek public comment on FDA's approach to regulating nucleic acid testing for infectious agents when intended for use in blood donor screening and/or manufacturing of blood products. FDA is issuing the draft guidance document in response to requests from manufacturers for guidance in the development of nucleic acid testing of plasma pools for infectious agents.