Investigational New Drug (IND) Application: The Gateway to Clinical Trials
The Investigational New Drug (IND) application is a critical step in the drug development process. It's the formal request submitted to regulatory authorities, most notably the U.S. Food and Drug Administration (FDA), to gain permission to administer an investigational drug to humans in clinical trials. This application serves as a comprehensive package of information demonstrating the drug's potential safety and efficacy for its intended use.
What is an IND Application?
An IND application is not an approval to market a drug. Instead, it's a notification to the regulatory agency that the sponsor intends to conduct clinical investigations. The agency then has a period (typically 30 days) to review the application. If no objections are raised, the sponsor can proceed with initiating clinical trials. The IND bridges the gap between preclinical research (laboratory and animal studies) and human testing.
Key Components of an IND Application
| Component | Description | Purpose |
|---|---|---|
| Chemistry, Manufacturing, and Controls (CMC) | Details on the drug substance, drug product, manufacturing process, and quality control measures. | Ensures drug quality, purity, and consistency. |
| Pharmacology | Information on how the drug works in the body (mechanism of action) and its effects in preclinical models. | Demonstrates potential therapeutic benefit and understanding of drug action. |
| Toxicology | Results from animal studies assessing the drug's safety, including acute and chronic toxicity, carcinogenicity, and reproductive toxicity. | Identifies potential risks and establishes safe starting doses for human trials. |
| Clinical Protocol(s) | Detailed plan for the proposed human studies, including objectives, study design, patient selection criteria, dosage, administration, and safety monitoring. | Outlines how human safety and efficacy will be evaluated. |
| Investigator's Brochure (IB) | A compilation of all clinical and preclinical data on the investigational drug that is relevant to the safety and efficacy of the drug. | Provides essential information to investigators conducting the clinical trials. |
Types of IND Applications
There are several types of IND applications, each serving a specific purpose in the drug development pathway:
The IND Review Process
Once submitted, the IND application undergoes a 30-day review period by the regulatory agency. During this time, the agency assesses the application for potential safety concerns. If the agency has no objections, the sponsor can proceed with initiating the proposed clinical trials. If concerns arise, the agency may place a 'clinical hold' on the IND, preventing the initiation or continuation of trials until the issues are resolved. This review process is crucial for safeguarding public health.
The IND application is a dynamic document. As new information becomes available from ongoing clinical trials, sponsors are required to submit amendments to the IND to keep the agency informed of any significant findings, particularly those related to safety.
IND vs. NDA: Understanding the Difference
It's important to distinguish the IND from the New Drug Application (NDA). The IND is for gaining permission to test a drug in humans, while the NDA is submitted after clinical trials are completed to seek approval to market the drug for a specific indication. The IND is the first step in the regulatory pathway for new drugs, while the NDA is the final step before a drug can be made available to the public.
To obtain permission from regulatory authorities to administer an investigational drug to humans in clinical trials.
30 days.
Chemistry, Manufacturing, and Controls (CMC); Pharmacology; Toxicology; Clinical Protocol(s); Investigator's Brochure (IB).
Learning Resources
The official FDA guidance on the IND application process, detailing requirements and procedures for submission.
A comprehensive overview from the FDA explaining the steps involved in submitting and managing an IND application.
A foundational FDA guidance document providing detailed recommendations for IND submissions.
A scientific article discussing the significance and components of the IND application within the broader context of drug development.
An industry-focused explanation of the IND application, its purpose, and key considerations for sponsors.
An overview of the entire drug development process, placing the IND application within its historical and functional context.
Explains translational medicine, highlighting how IND applications are a key component in moving research from the lab to clinical application.
A video explaining the FDA's drug approval process, including the role and importance of the IND application.
An article from a professional regulatory affairs organization discussing the IND application and its strategic importance.
A general overview of the IND application, its history, and its role in drug development.