Journal Article

Development of Probiotics as Biologic Drugs

Freddie Ann Hoffman

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 46, issue Supplement_2, pages S125-S127
Published in print February 2008 | ISSN: 1058-4838
Published online February 2008 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/523326
Development of Probiotics as Biologic Drugs

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In the United States, probiotics that are intended to be used to diagnose, cure, mitigate, treat, or prevent disease in humans or other animals and that affect the structure or the function of the body are considered to be drugs. This article provides a brief overview of the historical basis of US regulation of drugs and biologics and explores the legal, regulatory, and policy considerations for probiotics as biologic drugs for humans.

Journal Article.  2217 words. 

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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