Essentials of US IND Application

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About the IND Application

An Investigational New Drug (IND) is a comprehensive description of the safety, quality, and scientific rationality of a new drug, and it is the necessary step for any innovative drug to proceed to clinical trials. The core purpose of an IND application is to prove to the regulatory authorities that the proposed clinical trial will not pose unreasonable risks to the subjects, and that the trial has a sufficient scientific basis and ethical considerations.

In the U.S., the FDA reviews IND applications in accordance with the law. Review of an IND application is usually completed within 30 days after submission. If the FDA does not issue a Clinical Hold notice during this period, the sponsor can initiate the clinical trial; otherwise, the sponsor must make the necessary modifications based on the questions raised by the FDA and resubmit the application until approval is obtained.

IND Application Materials

IND application documents usually follow the eCTD format and mainly consist of the following key modules.

1. Forms and Administrative Information

This part constitutes the administrative framework for IND. The sponsor must ensure the accuracy of the information.

FDA Form 1571
FDA Form 1572
Table of Contents
Introductory Statement and General Investigational Plan

2. Investigator's Brochure (IB)

The IB section provides comprehensive information about the new drug for clinical researchers.

Drug Description
Non-clinical studies, including pharmacology, pharmacokinetics, and toxicology
Human Experience (if applicable)
Potential Risks and Benefits

3. Chemistry, Manufacturing and Controls (CMC)

CMC is used to ensure the quality, purity, stability, and consistency of the new drug.

Drug substance
Drug product
Production facility information

4. Clinical Information

This section provides a detailed description of the clinical trial to be conducted, and it serves as the primary basis for the FDA to assess the ethical and scientific aspects of the trial.

Clinical protocol
Informed consent form (ICF)

5. References

This section lists all the scientific literature, research reports and public data cited in the IND.

Key Points of the IND Application

All submitted data must be true, accurate and complete.
The design and implementation of each study should follow the highest scientific standards.
Strictly follow the requirements of 21 CFR Part 312.
Use professional and precise language, avoiding vague descriptions and redundant information.
Fully identify potential risks and propose corresponding monitoring, intervention and management strategies.
Communicate with the FDA through the Pre-IND meeting to discuss the key issues.
After submitting the IND, any major changes to the research plan, drug production or safety information, etc., need to be reported to the FDA promptly through an IND Amendment.
Submit an IND annual report to the FDA annually, summarizing the research progress and safety data for the past year.

Our Services

The IND application is a systematic, highly demanding and complex task, which not only tests the scientific strength of the applicant, but also assesses their understanding and execution ability of regulations. Proregulations specializes in providing professional services for the preparation and review of IND application materials for enterprises and research institutions in the global pharmaceutical and healthcare sector, ensuring that the submitted materials comply with the regulations of the FDA and avoiding clinical delays caused by data omissions or format issues.

Here are some of the relevant compliance services we provide:

Interpretation and consultation on regulatory standards
Regulatory training
Product registration strategy planning
Writing and optimizing of IND application documents
Professional pre-review of IND application materials
Electronic submission of IND
Revision and annual report management of IND
Compliance assessment
Risk management
Communication with FDA

Proregulations is committed to assisting clients in efficiently organizing and submitting all modules required for the IND application, ensuring the data integrity, scientific rigor and regulatory compliance of the application materials. If you are interested in our services, please contact us.