What is an IND?

What is an IND?

What is an IND?

IND refers to Investigational New Drug. Investigation New Drug Applications are submitted to the FDA prior to the product’s approval and marketing for that indication.

Related FAQs
  • Must I submit an investigator’s brochure to the IRB when the IRB is reviewing an investigational drug study?

    ​Yes. For studies conducted under an IND the FDA requires that an investigator’s brochure be submitted. Although not mentioned specifically in 21 CFR part 56, much of the information contained in the IB is clearly required to be reviewed by the IRB such as assuring the risks to the participants are reasonable in relation to the anticipated benefits which cannot be adequately evaluated without the review of the IRB.

  • What is an IDE?

    ​IDE refers to investigational device exemption. A device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

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