U.S. FDA Investigational New Drug Application (IND)

US FDA Investigational New Drug Application (IND)

What is an Investigational New Drug Application (IND)?

Current United States federal law requires that in order for a drug to be authorized to be transported or distributed across state lines and/or be distributed to humans, it must be the subject of an approved marketing application. As clinical study sponsors will want to administer their new drug product to clinical trial patients in many different states as part of their pre-market research, they need an exemption to this law to properly conduct their studies.

An Investigational New Drug Application (IND) is a formal request from a clinical study sponsor to obtain this exemption from the United States Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans as part of the drug’s pre-market safety and efficacy research.

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Application Types and Classifications

Applications are categorized by their intended use; either commercial or research (non-commercial). Under these categories, IND’s are classified as one of three types:

Investigator IND
This application is submitted by the physician responsible for both initiating and overseeing the investigation. The investigational drug is administered or dispensed under the immediate direction of this physician. A research IND may be submitted by a physician to propose the study of an unapproved drug or an approved product for a new indication or in a new patient population.
Emergency Use IND
This application type enables the FDA to authorize the use of an experimental drug in emergencies where there is no time for the submission of a standard IND, as outlined in 21 CFR, Sec. 312.23 or Sec. 312.20. This submission is also employed when patients do not meet the criteria of an existing study protocol or when no approved study protocol currently exists.
Treatment IND
Submitted for experimental drugs demonstrating promise in clinical testing for serious or immediately life-threatening conditions, this application type allows for the administration of the drug while final clinical work is conducted and the FDA review takes place.
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What’s Included in an IND Application?

Formatting and Administrative Documents

 

  • The content and format of an IND submission must be complete, well-organized as per 21 CFR 312, and include all applicable FDA Forms.
Animal Pharmacology and Toxicology Studies

 

  • Applicants must provide adequate preclinical data for the FDA to assess whether the product is reasonably safe for initial testing in humans. Any previous experience with the drug in humans (often foreign use) should also be included.
Manufacturing Information
  • Applicants must include all information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can consistently produce quality batches of the drug.
Clinical Protocols and Investigator Information
  • It is required for applications to include detailed protocols for proposed clinical studies for the agency to assess whether the initial-phase trials will expose subjects to unnecessary risks. Information on the qualifications of the clinical investigators must also be included. Finally, applicants must include commitments to obtain informed consent from the research subjects, to obtain a review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations throughout the clinical trials.

The IND Submission Process

The IND Submission Process begins once the applicant submits their final and complete application to the FDA, including the results of all necessary Animal Pharmacology and Toxicology Studies. 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.

 

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