What is an IND?
An Investigational New Drug (IND) application is filed with the FDA when a pharmacological agent is being tested for safety and effectiveness in humans or when an FDA approved drug is being used in a different dosage, for a different purpose, or in a different population than previously approved by the FDA. When an application to test the drug is filed with the FDA, an IND number is issued for the drug. Additional information is available on the FDA website: http://www.fda.gov/ oc/ohrt/irbs/drugsbiologics.html.
An Investigational New Drug (IND) application is filed with the FDA when a pharmacological agent is being tested for safety and effectiveness in humans or when an FDA approved drug is being used in a different dosage, for a different purpose, or in a different population than previously approved by the FDA. When an application to test the drug is filed with the FDA, an IND number is issued for the drug. Additional information is available on the FDA web site: http://www.fda.gov/ oc/ohrt/irbs/drugsbiologics.html. • What is an IDE? An Investigational Device Exemption (IDE) is the mechanism by which new medical devices that could impose “significant risk” to patients/subjects are tested in the U.S. An IDE allows an investigational device to be utilized in a study in order to gather information on the safety and efficacy (effectiveness) of the device. An IDE is also required for an approved device which is being used off-label in a research study. Additional information is available on the
