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# Live Biotherapeutic Product Guidance Out
- URL: https://www.fdaweb.com/live-biotherapeutic-product-guidance-out/
- Published: 2016-06-30T12:00:00.000Z
- Updated: 2026-09-14T21:12:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136091

FDA has issued a guidance, *Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing and Control Information*, to assist IND sponsors with submissions for early clinical trials with live biotherapeutic products (LBP), including those lawfully marketed in the U.S. as foods, such as conventional foods and dietary supplements. The [document](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/UCM292704.pdf?ref=fdaweb.com) focuses on the chemistry, manufacturing, and control (CMC) information that should be submitted in an IND for a LBP. It applies to all INDs of LBPs, whether clinical trials are conducted commercially, in an academic setting, or otherwise under applicable regulations. It does not, however, apply to LBPs intended as gene therapy, vectors, to oncolytic bacteria, or to oncolytic viruses.

This guidance updates one issued in 2/2012 by including a new section to address when the label on commercially available products would be considered adequate to satisfy the purpose of the CMC information requirements. It also removes the General Safety Test as an example of a test method, and updates certain footnotes, references, and addresses.

The document includes Introduction and Background, Administrative and Regulatory Procedures, CMC Information, Non-Clinical Information, Clinical Information, and References.