Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability, and Reporting Certain Changes to an Approved Application; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application" dated November 2010. The guidance document provides recommendations to blood establishments for training of back-up personnel, assessment of blood donor suitability, and how to report certain changes to an approved license application to FDA. The guidance announced in this document finalizes the draft guidance entitled "Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus" dated November 2009. The guidance announced in this document also is superseding certain recommendations in two previous guidances, the guidance document entitled "Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture" dated July 2001 and the guidance document entitled "Guidance for Ind