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The immense scope and breadth of the FDA regulations is often underestimated by researchers. To put this into perspective, consider the following questions:

Question: When do FDA regulations apply to my research?

FDA-regulated human subject research includes all human subject research that is conducted using an FDA-regulated product – whether or not there is an IND (Investigational New Drug application) in place.

Question: What does the FDA regulate?

Food, Drugs, Biologics, Medical Devices, Radiation-Emitting Products, Dietary/Nutritional Supplements, Cosmetics and Veterinary Products.

FDA-regulated products account for $.25 of every consumer dollar spent in
the US!