Submission of an Investigational New Drug Application (IND) to CBER

An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application.

Please refer to the “Additional Resources” section below for useful information on the development and submission of INDs.

IND Content and Format

The content and format of an IND submission must be complete, well-organized as per 21 CFR 312, and include all applicable FDA Forms, provided below. These forms can also be found in FDA’s Form Database.

• Form FDA 1571: Investigational New Drug Application
  • For Individual patient INDs, a licensed physician may use Form FDA 3926: Individual Patient Expanded Access IND in place of the Form FDA 1571
• Form FDA 1572: Statement of Investigator
• Form FDA 3454: Certification: Financial Interests and Arrangements of Clinical Investigators
• Form FDA 3455: Disclosure: Financial Interests and Arrangements of Clinical Investigators
• Form FDA 3674: Certification of Compliance

Submission of an IND

Sponsors of commercial INDs and all subsequent amendments are required to submit information electronically in the electronic Common Technical Document (eCTD) format. For electronic submission in eCTD, see Information on Regulatory Submissions in Electronic Format for Biologic Products. IND sponsors should request a submission tracking number (STN) from CBER prior to an eCTD submission. Detailed procedures are outlined in SOPP 8117: Issuing Tracking Numbers in Advance of Electronic Submissions in eCTD Format.

While non-commercial/research IND sponsors are exempt from the requirement for electronic submissions, they are encouraged to submit electronically using the eCTD format. For specific instructions on how to submit eCTD exempt non-commercial/research INDs to CBER, please refer to SOPP 8110: Submission of Regulatory Applications- Exempt from eCTD Requirements. General questions regarding the submission of an IND to CBER may be directed to industry.biologics@fda.gov.

Submission of an Emergency IND

• Initial submission of an IND for emergency use: During normal business hours (i.e., 8:00 AM – 4:30 PM, Monday to Friday), contact CBER’s Office of Communication, Outreach and Development of by phone at 240-402-8010 or 800-835-4709 ; or by email at: industry.biologics@fda.gov.
• After working hours and on Federal Holidays, Phone FDA's Emergency Call Center at 866-300-4374 or 301-796-824

Additional Resources

• Investigational New Drug Applications (INDs) for CBER-Regulated Products
• Information on the Use of Antivenoms
• Standard Operating Policies & Procedures (SOPPs)

Guidance Documents

• Link to FDA and CBER’s Guidance Database
• Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions
• Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers

Code of Federal Regulations (CFR)

• Investigational New Drug Application – 21 CFR 312
• Requirements for Adequate and Well-controlled Clinical Studies - 21 CFR 314.126: These requirements pertain to studies submitted in support of new drug applications (NDAs) for drugs, but most of the concepts are also relevant to biological products
• Protection of Human Subjects – 21 CFR 50
• Financial Disclosure by Clinical Investigators – 21 CFR 54
• Institutional Review Boards – 21 CFR 56
• Good Laboratory Practices for Nonclinical Laboratory Studies – 21 CFR 58
• Current Good Manufacturing Practice in Manufacturing, Processing, Packaging or Holding of Drugs – 21 CFR 210
• Current Good Manufacturing Practice for Finished Pharmaceuticals - 21 CFR 211
• Regulations for Biological Products - 21 CFR 600
• General Biological Products Standards - 21 CFR 610: These regulations include descriptions of the general safety and sterility tests that are performed on biological products administered by parenteral routes. The General Safety test is performed primarily as a check on the adequacy of the filling procedure of the final containers and is not intended as a safety test of the product itself. Both bulk and final container sterility tests should be performed as described in Section 610.12. The lot number together with the results of all tests performed on each lot of product should be submitted prior to use in clinical trials.