The FDA’s guidelines on when human research studies require an Investigational New Drug (IND) application can be a maze for researchers and sponsors. In this episode, we break it all down for you: from the broad definition of “drugs” under the FD&C Act to exemptions in clinical investigations. We discuss the core criteria that help you determine if your research falls under the IND requirements and how to avoid common pitfalls.
Whether you’re working with new compounds, marketed drugs, or even live organisms, understanding IND requirements is crucial for safety and regulatory compliance. Tune in now to learn more!
KGK Science has been delivering top-notch clinical research trials and expert regulatory support for the nutraceutical, cannabis, hemp, and psychedelic industries for over 27 years, aiding companies in bringing their products to global markets with custom trials and claim substantiation strategies.
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