Are Investigational New Drug (IND) applications required for clinical studies of botanical products that are also lawfully marketed as dietary supplements in the U.S.?
Yes. If a lawfully marketed botanical dietary supplement is studied for its effects on diseases in the proposed investigation (i.e., to cure, treat, mitigate, prevent, or diagnose disease including its associated symptoms), then it is an investigational new drug and will be subject to IND requirements. This applies to studies in INDs sponsored for both commercial and academic research purposes.
Related Questions
- Will the DCC prepare investigational new drug (IND) applications for Specialized Center clinical studies or will the DCC provide advice with a Specialized Centers on how to prepare an IND application?
- Are Investigational New Drug (IND) applications required for clinical studies of botanical products that are also lawfully marketed as dietary supplements in the U.S.?
- Can Sigma Aldrich products be used in clinical applications?
