Do I Need an IND?

Is an Investigational New Drug Application Required?

An investigator is always required to submit an Investigational New Drug (IND) application to study an unmarketed (i.e. unapproved) medical drug or biologic. An investigator may be required to submit an IND application to the FDA in order to study a marketed medical drug or biologic in a new (i.e. unapproved) clinical indication. In both cases, the products are considered “investigational” by the FDA.

For guidance on how to proceed for your unmarketed drug or biologic, or to determine if an IND application must be submitted to study a marketed drug or biologic, click here to request a consultation from our team of experts.

Navigating the IND Application

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IND Initial Application

The required components of an initial IND submission are very well defined by the FDA. They are:

  • Cover Letter
  • Form 1571
  • Form 1572
  • Form 3674
  • Table of Contents
  • Introductory Statement and General Investigational Plan
  • Chemistry, Manufacturing, and Control Information (CMC)
  • Pharmacology/Toxicology Information
  • Investigator’s Brochure
  • Clinical Protocol(s)
  • Summary of Previous Human Experience with the Investigational New Drug
  • Additional Information, if applicable (e.g. drug dependence and abuse potential, pediatric studies, etc.)
  • Other Relevant Information, if applicable or if requested by FDA

The ICTR IND/IDE team can help you navigate these requirements by providing templates, examples and guidance documents, please click here to request help.

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IND Application Reporting

Sponsors of IND applications are responsible for sending periodic updates and reports related to their applications to FDA. Refer to this table for guidance on the requirements and timing for the various types of IND amendments and the IND Annual report.

All submissions with IND amendments or reports must have Form 1571 sent along with the respective amendment or report.

Form 3674 must be submitted for all new clinical trials (protocols).

Form 1572 must be included if the amendment concerns change in application sponsor or addition of a new investigator.

For any given IND application, FDA may receive the following categories of amendments and reports:

The ICTR IND/IDE team can help you navigate these requirements by providing templates, examples and guidance documents, please click here to request help.

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FAQs

Click here for answers directly from FDA on a variety of issues related to Investigational New Drug Applications.