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U.S. Department of Health and Human Services

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Curr Issues Mol Biol 2008;10(1-2):13-6

Considerations in the development of live biotherapeutic products for clinical use.

Ross JJ, Boucher PE, Bhattacharyya SP, Kopecko DJ, Sutkowski EM, Rohan PJ, Chandler DKF, Vaillancourt J

Ross JJ (reprint author), US FDA, Div Vaccines & Related Prod Applicat, Rockville, MD 20857 USA US FDA, Div Vaccines & Related Prod Applicat, Rockville, MD 20857 USA US FDA, Ctr Biolog Evaluat & Res, Div Bacterial Parasit & Allergen Prod, Off Vaccines Res & Review, Rockville, MD 20857 USA Novartis Vaccines & Diagnost, I-53100 Siena, Italy


Food products in the United States (U.S.), including dietary supplements, may contain live microorganisms and can be promoted for general health, nutritional, or structure/function claims. In contrast, such preparations used with the intention of having a preventive or therapeutic effect in humans are regulated by the Food and Drug Administration (FDA) in the U.S. as biological products, specifically as live biotherapeutic products (LBPs). Discussion of considerations in the early development of LBPs may aid in preparation of an Investigational New Drug Application (IND) that is designed to collect clinical data to support marketing approval of a LBP in the U.S. for a specific clinical use. Product information is an important component of an IND to support a proposed clinical study.

Category: Journal Article, Review
PubMed ID: #18525102
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2011-10-04 Entry Last Modified: 2012-08-29