Investigational New Drug Application (IND)

An IND application is the means by which pharmaceutical companies/investigators obtain authorization/exemption from the FDA to start human clinical trials and ship the investigational drug or biological products across state lines prior to a marketing application being approved, as currently required by Federal law.

Choosing the right IND application:

  • Commercial IND: filed by pharmaceutical companies looking to be granted marketing approval for a new drug.
  • Research/investigator IND: submitted by investigators who want to study unapproved drugs or approved drugs for new indications.
  • Emergency IND: allows authorization to use an experimental drug for an emergency situation, for patients who do not meet criteria for the current protocol, or if an approved study protocol does not exist.
  • Treatment IND: filed by pharmaceutical companies for experimental drugs prior to FDA approval, for treatment of severe or life-threatening conditions.

The IND application must contain information about:

  1. Animal pharmacology and toxicology studies containing preclinical data for assessment of safety for initial human studies. This includes previous experience with drugs in human use for other indications, or in foreign use.
  2. Manufacturing information regarding composition and stability testing to ensure adequate and consistent supply of the drug.
  3. Details regarding the proposed clinical study: clinical protocols to assess for potential risk; qualifications of investigators; commitments to obtain informed consent from participants, review of study by an IRB, and to follow current regulations.

Source: Investigational New Drug (IND) Application. (2021, February 24). U.S. Food and Drug Administration. Retrieved January 8, 2022, from