IND Application Procedures: Overview
When submitting original IND applications, sponsors are expected to send their applications in triplicate (one original and two copies). Electronic submissions should be considered whenever possible (FDA Study Data Standards Resources).
Each application should be accompanied by:
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Form 1571 (PDF - 830KB) (IND application cover),
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Form 1572 (PDF - 718KB) (Investigator’s statement), and
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Form 3674 (PDF - 3MB) (certification requirement & mandatory registration and reporting of results for applicable clinical trials through ClinicalTrials.gov.)
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While IND application sponsors are not required to submit information regarding clinical investigators’ financial interests or arrangements in the original IND applications, they are expected to collect this information before a clinical investigator participates in a clinical study. For further information refer to Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators (PDF - 165KB).
The current address for sending IND applications may be found at Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs).
Upon receipt of an IND application, FDA will notify the sponsor of the date it receives the application through an IND acknowledgment letter.
An IND application may go into effect:
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30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or
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on earlier notification by FDA that the clinical investigations in the IND may begin.
Once an IND application is in effect, a drug manufacturer may ship the investigational new drug to the investigator(s) named in the application. An investigator may not administer an investigational new drug to human subjects until the IND application goes into effect.
In addition to knowing the requirements for safety and other reporting, investigators submitting IND applications should be familiar with procedures pertaining to the following:
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Exemptions from IND application submission requirements.
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Interactions with FDA.
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Procedures related to Clinical Hold.