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