Investigational New Drug (IND)

IND is a submission made to the FDA requesting authorization to initiate study of a new drug products

FDA requires an IND containing data of the new drug to decide if a new drug will pose a reasonable risk to human subject that will participate in the study

IND would be required under the following circumstances:

  • A new chemical Moiety
  • A drug that is being given at a new dosage level
  • A drug in combination with another drug and the combination is not yet approved
  • All clinical studies where a new drug is administered to human subjects

Commercial IND is Submitted by companies seeking approval for a new drug
Research INDs (Non-Commercial) are filed by researchers to study an unapproved drug or to study an approved drug for a new indication or in a new patient population
Emergency Use INDs are filed for emergency use of an unapproved drug when the clinical situation does not allow enough time to submit an IND according to the FDA regulation. These are most commonly used for life-threatening conditions for which there is no standard treatment.
Treatment INDs are filed to make a drug available for treatment of serious or immediately life-threatening conditions prior to FDA approval

Content and format of an IND application

  • Form FDA 1571 and 3674
  • Table of contents
  • Introductory statement
  • General investigational plan
  • Investigator’s brochure
  • Protocol(s): study protocol(s), investigator data, facilities data, Institutional Review Board (IRB)
  • Chemistry, Manufacturing, and Control (CMC) data, including environmental assessment or claim for exclusion (assuming the draft of CMC information exists)
  • Nonclinical: pharmacology and toxicology data
  • Clinical: previous human experience
  • Additional information to support the IND filing

Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials
During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk
CDER’s Pre-IND Consultation Program fosters early communications between sponsors and new drug review divisions to provide guidance on the data necessary to warrant IND submission

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