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Zdrowie i gospodarka · 26.03.2009

Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Source Plasma Establishments

The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation to participate in a pilot evaluation program for CBER's eSubmitter Program (eSubmitter). CBER's eSubmitter has been customized as an automated biologics license application (BLA) and BLA supplement (BLS) submission system for blood and blood components. Participation in the pilot program is open to blood establishments that collect Source Plasma. The pilot program is intended to provide industry and CBER regulatory review staff the opportunity to evaluate the eSubmitter system and determine if it facilitates the BLA/BLS submission process. The purpose of this notice is to invite blood establishments that collect Source Plasma to submit a request to CBER if they are interested in participating in this pilot program.

Source: Federal Register — Food and Drug AdministrationOpen original release →