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# Lot Release Protocol Submission Guidance
- URL: https://www.fdaweb.com/lot-release-protocol-submission-guidance/
- Published: 2019-02-27T12:00:00.000Z
- Updated: 2026-09-15T01:08:21.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5143483

CBER has issued a guidance, *Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format*, to assist manufacturers of biological products regulated by CDER to submit lot release protocols in electronic format. The [document](https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/UCM179118.pdf?ref=fdaweb.com) updates and supercedes a 2007 guidance. The agency says the guidance was updated to include submission of electronic lot release protocols through the FDA electronic submission gateway.