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GUIDANCE DOCUMENT

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

Final Level 2 Guidance
Docket Number:
1998D-0315
Issued by:
Guidance Issuing Office
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).


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 1998D-0315.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010