| August 10, 2021 D. Craig Hopp, Ph.D.
Wendy J. Weber, N.D., Ph.D., M.P.H. If you're planning to submit a grant application for a clinical trial involving a natural product, check out our new Natural Products Clinical Trials Resource. It can help you understand the U.S. Food and Drug Administration (FDA) regulatory requirements for research on natural products, including the need for an Investigational New Drug (IND) application for some clinical trials. And we hope it will help you smoothly navigate the requirements that apply to your proposed study. The new resource includes: - A flow chart for the process for determining whether the FDA may require an IND application for your proposed research, with tips for interacting with the FDA regarding the IND process.
- Information about helpful FDA regulatory documents and resources, including instructions for submitting an IND application, guidance on obtaining exemptions from IND requirements, and resources on botanical drug development.
- Definitions of terms important in the regulation of dietary supplements and other natural products, such as Generally Recognized as Safe (GRAS) and new dietary ingredient (NDI).
- Answers to frequently asked questions about when INDs may be needed for NCCIH funded research.
- Examples of natural products clinical trials funded by the National Center for Complementary and Integrative Health (NCCIH).
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