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  1. FDA eSubmitter

Blood Products eSubmitter Program

The Office of Blood Research and Review within the Center for Biologics Evaluation and Research (CBER) is utilizing the FDA eSubmitter tool to allow Industry to create an electronic application for Whole Blood and blood components including Source Plasma for submittal to the FDA. The eSubmitter program is intended to facilitate submission and processing of regulatory filings, including biologics license applications (BLAs), BLA supplements (BLSs), annual reports and amendments to pending eSubmitter applications and supplements.

FDA’s guidance document: Guidance for Industry: Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments provides additional details on the program.

If you need additional assistance with eSubmitter, please send an email to: CBER_eSubmitter_program@fda.hhs.gov and you will be contacted shortly.

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