Zdrowie i gospodarka · 11/07/2001

"Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier;" Availability

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier" dated July 2001. The guidance document is intended to assist manufacturers of Source Plasma who wish to participate in the Center for Biologics Evaluation and Research (CBER) pilot program for Red Blood Cell immunization. The pilot program would allow a licensed manufacturer of Source Plasma to self-certify conformance to specific criteria and recommendations described by CBER in the guidance document in lieu of submission of a detailed biologics license application supplement filing. The guidance document announced in this notice finalizes the draft guidance document entitled "Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier" dated June 2000.