What Is an Investigational New Drug Application (IND)?

An Investigational New Drug Application (IND) is an application or request that a sponsor submits to the US FDA allowing them to administer an investigational drug to humans in clinical trials. It is required before a new pharmaceutical or biologic product can be testing in humans for the purpose of obtaining data on its safety and effectiveness. It is a critical step in the drug development and requires meticulous preparation and adherence to FDA regulations, with the goal of advancing the drug development process efficiently and ensuring product quality, safety, and scientific evidence.

What Are the Types of INDs?

This process involves thorough preparation, including a well-executed Pre-IND Meeting strategy. Approval of the IND application is required before sponsors can transport their drug across state lines and commence clinical trials. The goal is to expedite the trials, ultimately bringing the product to market sooner.

There are 3 types of INDs:

Investigator IND: this is submitted by a physician who initiates and conducts and investigation.

Emergency Use IND: this facilitates the authorization of an experimental drug in an emergency situation by the US FDA.

Treatment IND: this is submitted for experimental drugs which demonstrate promise in clinical testing for serious and/or life-threatening conditions, while the final clinical work and FDA review is being conducted.

There are two IND categories:

Commercial (filed by pharmaceutical companies)

Research/ Non-commercial (filed by researchers)

Submitting INDs

Submitting an IND application is a multifaceted process and should contain information on animal pharmacology & toxicology data, manufacturing information, clinical protocols and investigator information. After the IND has been submitted, sponsors must wait 30 calendar days before they can proceed with clinical trials. During this period, the US FDA may review the safety aspect of the IND to ensure that participants shall not be subject to risk.

Sponsors must submit 1 original IND application and 2 copies where each original application should be supplemented by the IND application cover, investigator’s statement, certification requirement, mandatory registration, and results for applicable clinical trials.

DDReg’s Capabilities

DDReg guides sponsors through the entire IND process, from pre-IND meetings to IND approval:

Formulating a strategic approach for IND submission.

Planning for pre-IND meetings with the FDA.

Assessing data requirements and regulatory pathways.

Compiling safety, efficacy, pharmacology, and toxicology data.

Drafting IND application forms and investigator agreements.

Preparing for pre-IND meetings with the US FDA.

Addressing regulatory questions and ensuring alignment with FDA expectations.

Support in drafting IND cover letter, investigator's brochure, and protocols.

Serving as intermediaries between the company and the FDA.

Facilitating communication and addressing FDA questions or concerns

Ensuring compliance with FDA regulations and guidelines throughout the IND submission process.

Assisting with electronic IND submissions and amendments.

Drafting and compiling query responses for the FDA.

Providing continuous support throughout the IND approval process.

Assisting with IND amendments, safety reporting, and other regulatory requirements.

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