title: Development of probiotics as biologic drugs.
abstract: 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.
authors.affiliation: HeteroGeneity, Washington, DC 20011, USA. fhoffman@heterogeneity-LLC.com
authors.forename: Freddie Ann
authors.initials: FA
authors.lastname: Hoffman
mesh_terms: D000818:Animals; D001688:Biological Products / Q000592:standards* / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003257:Consumer Product Safety; D017277:Drug Approval; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D006801:Humans; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products