Botanicals as "new" drugs: US development

Epilepsy & Behavior : E&B
Freddie Ann Hoffman

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".

References

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Jun 23, 2015·Journal of Pain & Palliative Care Pharmacotherapy· U S Department Of Health And Human Services

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Citations

Oct 17, 2015·Epilepsy & Behavior : E&B·Siegward M Elsas, Nikolaus J Sucher
Sep 9, 2016·Expert Opinion on Drug Delivery·Carmelo PugliaGiovanni Puglisi
Oct 28, 2019·Current Medicinal Chemistry·Carmelo Puglia, Maria Rosaria Lauro

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