In Brief: MedImmune's RespiGam
Executive Summary
MedImmune's RespiGam: FDA's Blood Products Advisory Committee will review the PLA for RSV-IVIG product in the prevention of serious respiratory syncytial virus on Dec. 15. MedImmune amended its RespiGam PLA in September. The PLA was previously rejected by the committee. The committee also will meet in closed session at 2 p.m. on Dec. 15. On Dec. 14, in the morning the committee will hear FDA updates on Creutzfeldt-Jakob disease and HIV-1 screening, Trypanosoma cruzi testing of blood donors, and a report of an FDA-HRSA contract study of the U.S. tissue procurement distribution system. On the afternoon of Dec. 14, the committee will hear a summary of a workshop on cord blood and peripheral blood hematopoietic stem cell products intended for transfusion. The meeting begins at 8 a.m. on both days in conference rooms D & E of FDA's Parklawn building in Rockville, Md...
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MedImmune's RespiGam: FDA's Blood Products Advisory Committee will review the PLA for RSV-IVIG product in the prevention of serious respiratory syncytial virus on Dec. 15. MedImmune amended its RespiGam PLA in September. The PLA was previously rejected by the committee. The committee also will meet in closed session at 2 p.m. on Dec. 15. On Dec. 14, in the morning the committee will hear FDA updates on Creutzfeldt-Jakob disease and HIV-1 screening, Trypanosoma cruzi testing of blood donors, and a report of an FDA-HRSA contract study of the U.S. tissue procurement distribution system. On the afternoon of Dec. 14, the committee will hear a summary of a workshop on cord blood and peripheral blood hematopoietic stem cell products intended for transfusion. The meeting begins at 8 a.m. on both days in conference rooms D & E of FDA's Parklawn building in Rockville, Md.... |