title: Botanicals as "new" drugs: US development.
abstract: Botanicals are ingredients that can be marketed as foods, drugs, cosmetics, and medical devices in the United States. When a botanical is intended to diagnose, treat, prevent, mitigate, or cure a disease, it is considered to be a "drug". This article reviews the US regulatory requirements for botanicals as "new" drugs. An overview of the regulatory principles used to determine product category and the basic elements of an Investigational New Drug application and New Drug Application with the US Food and Drug Administration are presented. This article is part of a Special Issue entitled "Botanicals for Epilepsy".
authors: HeteroGeneity, LLC, Washington, DC, USA. Electronic address: fhoffman@heterogeneity-LLC.com.
authors: Freddie Ann
authors: FA
authors: Hoffman
mesh_terms: D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods*; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000379:methods* / Q000639:trends; D004827:Epilepsy / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D010936:Plant Extracts / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration / Q000639:trends
chemical_list: D010936:Plant Extracts
keywords: Botanical; Drug development; Food and Drug Administration; IND; Investigational New Drug; NDA; New Drug Application; New drug approval; Regulation