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Botanicals as "new" drugs: US development.

Freddie Ann Hoffman1

  • 1HeteroGeneity, LLC, Washington, DC, USA.

Epilepsy & Behavior : E&B
|August 31, 2015
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This review outlines US regulatory requirements for botanicals classified as drugs. It details the process for Investigational New Drug and New Drug Applications for botanical drugs, particularly for epilepsy treatment.

Keywords:
BotanicalDrug developmentFood and Drug AdministrationINDInvestigational New DrugNDANew Drug ApplicationNew drug approvalRegulation

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Area of Science:

  • Regulatory Science
  • Pharmacology
  • Botanical Medicine

Background:

  • Botanicals have diverse applications in the US, including food, cosmetics, and medical devices.
  • When intended for disease treatment, botanicals are regulated as drugs by the US Food and Drug Administration (FDA).

Purpose of the Study:

  • To review US regulatory requirements for botanicals intended for use as new drugs.
  • To provide an overview of regulatory principles for categorizing botanical products.
  • To outline the essential components of Investigational New Drug (IND) and New Drug Applications (NDA).

Main Methods:

  • Review of US Food and Drug Administration (FDA) regulations and guidelines pertaining to botanical drugs.
  • Analysis of regulatory principles for determining product classification (food, cosmetic, or drug).
  • Summary of key elements required for Investigational New Drug (IND) and New Drug Application (NDA) submissions.

Main Results:

  • Botanicals marketed for therapeutic purposes must comply with drug regulations.
  • Successful navigation of the regulatory pathway requires understanding product categorization and submission requirements.
  • The article provides a foundational understanding of the IND and NDA processes for botanical drug development.

Conclusions:

  • Compliance with FDA regulations is crucial for botanical products intended as drugs.
  • This review serves as a guide to the regulatory landscape for new botanical drugs in the US.
  • Understanding these requirements is essential for the successful development and approval of botanicals for conditions like epilepsy.