Investigational New Drug Application (IND):

An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans. IND regulations are contained in Title 21, Code of Federal Regulations, Part 312. Copies of the regulations, further guidance regarding IND procedures, and additional forms are available from the FDA Center for Drug Evaluation and Research, Drug Information Branch (HFD-210), 5600 Fishers Lane, Rockville, Maryland 20857, telephone (301) 827-4573 or toll free at 1-888-INFOFDA. In addition, forms, regulations, guidances, and a wide variety of additional information is available online at http://www.fda.gov/cder/. Forms may be accessed directly at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html.