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An Investigational New Drug Application (IND) is a request for 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.
The following forms and informational material are provided for assistance in preparing and submitting an IND for a biological product.
- Electronic IND Demo
- Investigational New Drug Application (Form FDA 1571) - Outlines the information required in an IND. All sections on form FDA 1571 must be addressed in the submission. Also, in signing the form, the sponsor agrees to certain important conditions that are summarized just above the section for the sponsor's signature.
- Statement of Investigator (Form FDA 1572) - When this form is completed by each investigator, the original signed copy must be given to the IND sponsor.
- IND Regulations - Title 21 of the Code of Federal Regulations (CFR), Part 312 (21 CFR 312) -
(PDF),
(Text)
- Current Good Manufacturing Practice in Manufacturing, Processing, Packaging or Holding of Drugs; General
(21 CFR 210)
- Current Good Manufacturing Practice for Finished Pharmaceuticals
(21 CFR 211)
- Biological Products: General
(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.
- Adequate and Well-controlled Clinical Trials (21 CFR 314.126) - Pertains to studies submitted in support of new drug applications (NDAs) for drugs, but most of the concepts are also relevant to biological products. (PDF),
(Text)
- Informed Consent of Human Subjects
(21 CFR 50, Subpart B)
- Institutional Review Boards
(21 CFR 56)
- Good Laboratory Practices for Nonclinical Laboratory Studies
(21 CFR 58)
- General guidances, guidelines and Points to Consider are available at http://www.fda.gov/cber/guidelines.htm. Guidances specific to IND submissions are available at http://www.fda.gov/cber/ind/indpubs.htm
- Good Clinical Practice in FDA-Regulated Clinical Trials
- SOPP 8201 - Issuance of and Response to Clinical Hold Letters for Investigational New Drug Applications
- SOPP 8202 - Handling INDs Submitted with Insufficient Copies
- SOPP 8007 - DCC Binding Procedures for Regulatory Documents
- Draft Guidance for Industry and Reviewers: Estimating the Safe Starting Dose in Clinical Trails for Therapeutics in Adult Healthy Volunteers -
(PDF),
(Text)
Information on ordering current and complete copies of the regulations over which FDA has jurisdiction (21 CFR), and how to subscribe to the Federal Register, may be obtained from the Superintendent of Documents, U.S Government Printing Office, Washington, D.C. 20402, 202-783-3238.
All Biological IND submissions must be made in triplicate and should be addressed as follows:
Center for Biologics Evaluation and Research
HFM-99, Room 200N
1401 Rockville Pike
Rockville, MD 20852-1448
Questions regarding IND submissions may be directed to the Manufacturers Assistance and Technical Training Branch, 800-835-4709 or 301-827-1800.
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