An Investigational New Drug (IND) application is a formal request submitted to the U.S. Food and Drug Administration (FDA) by a sponsor, such as a pharmaceutical company or research institution. It is a necessary step before any new drug or biological product can be tested in human clinical trials. The IND allows the study drug to be administered to people for research purposes. The IND process ensures clinical investigations proceed with appropriate safeguards for participants.
Why an IND is Required
The primary purpose of an IND is to protect the safety and rights of human participants. Before a new drug can be shipped across state lines for human testing, it must receive FDA authorization. Federal law mandates drugs have an approved marketing application before interstate transport. The IND provides an exemption, enabling sponsors to legally distribute the investigational drug to clinical sites.
The FDA’s oversight through the IND process minimizes potential risks to individuals during early-stage clinical studies. This regulatory step also ensures the scientific evaluation of the drug is adequate to assess its effectiveness and safety. Without an active IND, a sponsor cannot begin human trials.
What an IND Application Contains
An IND application is a comprehensive document providing detailed information across several key areas. It includes preclinical data demonstrating the drug’s safety and biological activity. This evidence allows the FDA to assess if the product is reasonably safe for initial human testing.
The application also requires manufacturing information, detailing how the drug is made, its composition, stability, and the quality controls used. This section ensures the drug can be consistently produced with appropriate purity and quality for clinical use.
The IND application must include detailed clinical protocols for proposed human studies. These protocols outline the study objectives, design, criteria for selecting participants, dosing regimens, and procedures for monitoring safety and efficacy. Information about investigator qualifications is also submitted, ensuring researchers are capable of overseeing the study according to regulatory and ethical standards.
How an IND is Reviewed
Upon submission, the FDA initiates a review process, lasting 30 days. The agency evaluates the application to ensure research participants will not be subjected to unreasonable risks. Experts assess the scientific validity and safety of the proposed trials, focusing on whether preclinical data supports human testing and if clinical protocols are well-designed.
The review can result in two main outcomes: the FDA may not object, allowing clinical trials to proceed, or it may issue a clinical hold. A clinical hold is imposed when the FDA identifies concerns, such as safety risks or incomplete information, preventing the trial from starting until addressed. The IND remains active throughout the drug’s clinical development, requiring sponsors to provide ongoing updates to the FDA. This ensures any new safety information or study amendments are promptly reviewed.