Investigation New Drug Development

When research involves a drug(s) not approved by the Food & Drug Administration (FDA) or a drug(s) which will be used for purposes not approved by the FDA and the drug(s) poses an increased risk, investigators are required to get clearance from the FDA prior to enrolling subjects in the research study.

This may be accomplished through completion and submission of an Investigational New Drug (IND) application (FDA Form 1571) to the FDA for review and consideration of approval. An IND application to the FDA is required for drugs not yet FDA approved and some uses of FDA-approved drugs for a non-FDA-approved purpose or population.

Exemption from an IND may be applicable if the proposed study meets ALL of the following criteria:

• The investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use
• The investigation is not intended to be used to support any other significant change in the labeling for the drug
• The drug being used in your investigation is lawfully marketed as a prescription drug product
• The investigation is not intended to support a significant change in the advertising for the product
• The investigation does not involve a route of administration that significantly increases the risks (or decreases the acceptability of risks) associated with the use of the drug product
• The investigation does not involve a dosage level that significantly increases (or decreases the acceptability of the risks) associated with the use of the drug product
• The investigation does not involve use of a patient population that significantly increases the risks (or decreases the acceptability of risks) associated with the use of the drug product
• The investigation does not involve any other factor that significantly increases the risks (or decreases the acceptability of risks) associated with the use of the drug product
• The investigation is in compliance with the federal regulations and institutional policy
  • 21 CFR 312.2
  • 21 CFR 56
  • 21 CFR 50.24
  • Institutional Review Board Policy
• The investigation is in compliance with 21 CFR 312.7, which means you are not promoting the drug studies as being safe and effective
• The investigation does not provide for an exception of informed consent as described within 21 CFR 50.24

The Trinity Health Office of Research & Innovation – West Michigan has experience in IND applications and requires that all investigators, who wish to conduct research meeting the requirements for submission of an IND application to the FDA, consult with a member of the Office of Research & Innovation staff during protocol development. For further assistance, please submit a consultation request.

The Trinity Health Regional Institutional Review Board must also be considered in this process.

Helpful Links

FDA Code of Federal Regulations:

• 21 CFR 50.24 – Protection of Human Subjects: Informed Consent of Human Subjects
• 21 CFR 56 – Institutional Review Boards
• 21 CFR 312.2 – Investigational New Drug Application: Applicability
• 21 CFR 312.7 – Investigational New Drug Application: Promotion of investigational drugs