Determining Whether A Dietary Supplement Study Requires an Investigational New Drug (IND)

Determining whether a dietary supplement study requires an investigational new drug (IND)

Does a study that claims their dietary supplement “promotes healthy joints and cartilage” or “helps with arthritis, joint, and muscle-related aches and pains,” require an IND? When evaluating dietary supplement studies, IRBs must determine whether an IND may be required before research is considered for approval.

This paper provides an overview of the requirements and potential actions an IRB may take in carrying out its responsibilities.

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