Federal Register Notice: FDA will hold a meeting of the Blood Products Advisory Committee 11/17 from 8 a.m. to 5:30 p.m. and 11/18, from 8:30 a.m. to 1 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact Bryan Emery or Joanne Lipkind, (240) 402-8054, bryan.emery@fda.hhs.gov and (240) 402-8106, joanne.lipkind@fda.hhs.gov. The committee will meet in open session to discuss strategies to manage iron deficiency associated with blood donation. It will also discuss proposed procedures for assuring donor safety for collections of blood from female donors with hemoglobin values of 12.0-12.4g/dL or a hematocrit value between 36 and 38. In the afternoon, the committee will meet in open session to discuss adverse reactions related to blood donation in teenage (16 to 18 years) donors, and the effectiveness of several mitigation measures.
On 11/18, the committee will meet to hear an informational session on Zika virus and blood safety in the U.S. Following the informational session, the committee will hear presentations on (1) The Transfusion Transmissible Infections Monitoring System; (2) a summary of the FDA workshop on new methods to predict the immunogenicity of therapeutic coagulation proteins; and (3) a summary of the FDA workshop on preclinical evaluation of red blood cells for transfusion. To view this notice, click here.