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U.S. Department of Health and Human Services

Drugs

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Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)

An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug that is not the subject of an approved new drug application.

IND regulations are contained in Title 21, Code of Federal Regulations, Part 312. Copies of the regulations, further guidance regarding IND procedures, and additional forms are available from the FDA Center for Drug Evaluation and Research, Drug Information Branch (HFD-210), 5600 Fishers Lane, Rockville, Maryland 20857, telephone (301) 827-4573 or toll free at 1-888-INFOFDA. In addition, forms, regulations, guidances, and a wide variety of additional information are available online on the FDA Web site.  

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 applicants, not pharmaceutical companies.

Form 1571: Investigational New Drug Application

Where to Send the Application:

The initial IND submission and each subsequent submission to the IND should be accompanied by a Form FDA 1571 and must be submitted in triplicate (the original and two photocopies are acceptable). Mailing addresses for initial IND submissions are:

For a Drug:

Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Rd.
Beltsville, Md. 20705-1266

 

For a Therapeutic Biological Product:

Food and Drug Administration
Center for Drug Evaluation and Research
Therapeutic Biological Products Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266
 

  FORM FDA 1572:

Copies of Form FDA 1572 with its attachments may be sent by the Sponsor-Investigator to FDA to satisfy Form FDA 1571, box 12, item 6 b-d. Information can be supplied in the form of attachments (such as a curriculum vitae) rather than entering that information directly onto the form, but this should be so noted under the relevant section numbers.

 

 Form FDA 3674

The Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) was enacted on September 27, 2007. Title VIII of FDAAA added new Section 402(j) to the Public Health Service Act (42 USC § 282(j)) and expanded the current database known as ClinicalTrials.gov to include mandatory registration and reporting of results for applicable clinical trials of human drugs (including biological products) and devices.

Title VIII further requires that, at the time of submission of an application under section 505 of the FDCA, including an Investigational New Drug application, the application must be accompanied by a certification that all applicable requirements of 42 USC § 282(j) have been met. Where available, such certification must include the appropriate National Clinical Trial (NCT) numbers. You may use Form FDA 3674, Certification of Compliance, under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank, to comply with the certification requirement. The form may also be found on the FDA Forms page.

In completing Form FDA 3674, you should review 42 USC § 282(j) to determine whether the requirements of that subsection apply to any clinical trial(s) referenced in your application. Additional information regarding the certification form is available on the FDAAA Certification to Accompany Drug, Biological Product, and Device Applications or Submissions Web page.  Additional information regarding the expansion of ClinicalTrials.gov is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.htm. Additional information on registering your clinical trials is available on the Protocol Registration System Web site.

Please note that FDA has published a draft guidance, Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff – Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, 42 U.S.C. § 282(j), Added by Title VIII of the Food and Drug Administration Amendments Acts of 2007. In this guidance, FDA recognizes that certain information and documents submitted to FDA typically bear no relationship to the type of information that Title VIII is designed to capture and that it would not further the purposes of the legislation if a certification were to accompany every type of information or document submitted to the Agency regarding a medical product regulated by FDA. Consequently, FDA identifies in the guidance several types of information and documents that typically need not be accompanied by this certification. For assistance in determining whether your submission of an application under section 505 of the FDCA must be accompanied by a certification, you may consult this guidance.

 

FDA Receipt of the IND:

Upon receipt of the IND by FDA, an IND number will be assigned, and the application will be forwarded to the appropriate reviewing division. The reviewing division will send a letter to the Sponsor-Investigator providing notification of the IND number assigned, date of receipt of the original application, address where future submissions to the IND should be sent, and the name and telephone number of the FDA person to whom questions about the application should be directed. Studies shall not be initiated until 30 days after the date of receipt of the IND by FDA unless you receive earlier notification by FDA that studies may begin.