Adverse Events Home Page
IND Decision Tool
IND Exemption Form
Introduction
Highlights of FDA History
FDA vs. OHRP
What FDA Regulates
FDA Authorities
FDA Centers
Clarifying the "new" in IND
Assessing Preclinical Data
Properties of the Study Drug
How the Data is Used
IND Submission
IND Holder Reponsibilities
 

Introduction

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!