Considerations in the development of live biotherapeutic products for clinical use.
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.
Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration/PHS, Rockville, MD, USA. jennifer.ross@fda.hhs.gov
Jennifer J
JJ
Ross
Philip E
PE
Boucher
Siba P
SP
Bhattacharyya
Dennis J
DJ
Kopecko
Elizabeth M
EM
Sutkowski
Patricia J
PJ
Rohan
Donna K F
DK
Chandler
Julienne
J
Vaillancourt
D001688:Biological Products / Q000096:biosynthesis* / Q000737:chemistry / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D015195:Drug Design; D006801:Humans; D019936:Probiotics / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
D001688:Biological Products