Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format Guidance for Industry February 2019

GUIDANCE DOCUMENT

• Docket Number: FDA-1998-D-0095
• Issued by: Center for Biologics Evaluation and Research

We, the Center for Biologics Evaluation and Research (CBER), within the U.S. Food and Drug Administration (FDA, the agency, or we), are issuing this guidance under Title 21 of the Code of Federal Regulations (CFR) 601.14(a) to assist you, manufacturers of biological products regulated by CBER,  in submitting lot release protocols in electronic format to CBER’s Product Release Branch, within the Office of Compliance and Biologics Quality (OCBQ).  This guidance updates and supersedes the similarly named guidance, “Guidance for Industry, Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols,” dated November 2007 (2007 guidance).  We are updating this guidance to include the submission of electronic lot release protocols through the FDA’s Electronic Submissions Gateway (ESG).

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