1. Determine Whether You Need an IND: the Pre-IND Process

Review the five requirements below to determine if your study qualifies for exemption from an IND (21 CFR 312.2).   The FDA Guidance Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted without an IND provides more detail on a range of issues, including the process for consulting with FDA if unsure.

If you think a pre-IND meeting is warranted please contact the VCTRS for assistance.  Templates for a meeting request letter and pre-IND briefing packet are under development.  In addition, please consult with your institutional IRB to determine whether a formal letter from FDA is required to document the waiver.

Exemptions– A drug that is lawfully marketed in the United States is exempt from the requirements for an IND if all of the following apply:

  1. The investigation is not intended to be reported to the FDA in support of a new indication for use or any other significant change in the labeling for the drug.
  2. The investigation is not intended to support a significant change in the advertising for a prescription drug product.
  3. The investigation does not involve a change in route of administration, dosage level, or patient population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with use of the drug product.
  4. The investigation is conducted in compliance with the requirements for IRB review (21 CFR 56) and informed consent (21 CFR 50).
  5. The drug may not be represented as safe or effective for the purposes for which it is under investigation, nor may it be commercially distributed or sold.

Contact VCTRS for assistance in determining the IND status of your clinical study.