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# Guidance on Biotherapeutic Products Clinical Trials
- URL: https://www.fdaweb.com/guidance-on-biotherapeutic-products-clinical-trials/
- Published: 2016-07-01T12:00:00.000Z
- Updated: 2026-09-14T21:13:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136104

*Federal Register* Notice: FDA is making available a guidance: *Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry*. It provides investigational new drug application (IND) sponsors with recommendations on IND submissions for early clinical trials with live biotherapeutic products in the U.S. The document updates a guidance of the same title dated 2/2012 by addressing when the label on the commercially available products(s) would be considered adequate to satisfy the purpose of the chemistry, manufacturing, and control information requirements. To download this guidance, click [here](http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/UCM292704?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-07-01/pdf/2016-15664.pdf?ref=fdaweb.com)