Get to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of INDs.

In addition to knowing the requirements for safety and other reporting, investigators submitting IND applications should be familiar with procedures pertaining to the following:

Mar 27, 2025 · Welcome to the Investigational New Drug (IND) Application page for products regulated by the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and …

Electronic submissions of IND applications and use of data standards are encouraged. Information related to electronic submissions may be found at FDA Study Data Standards …

Investigator’s Responsibilities This page provides the key points that investigators should consider in order to understand their responsibilities regarding an IND application.

This table provides links to information for investigators about submitting Investigational New Drug (IND) applications to FDA.

The following instructions address only the administrative aspects of preparing and submitting an IND and are intended primarily to provide assistance to individual Sponsor-Investigator …

IND Application Reporting: Overview Sponsors of IND applications are responsible for sending periodic updates and reports related to their applications to FDA.

Emergency IND requests for products not regulated by CDER/DAV should be directed to the appropriate point of contact for the FDA Center/Division in which the product is reviewed.

This component of an IND application is expected to contain information about pharmacological and toxicological (laboratory animals or in vitro) studies on the basis of which the sponsor of …