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  4. Investigational New Drug Applications (INDs) for CBER-Regulated Products
  5. Information on Submitting an Investigational New Drug Application
  1. Investigational New Drug Applications (INDs) for CBER-Regulated Products

Information on Submitting an Investigational New Drug Application

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.

  1. All Biological IND submissions must be made in triplicate and should be addressed as follows:

U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002

  1. Emergency Use IND Requests:
For investigational biological products regulated by CBER, call 240-402-8010 or 800-835-4709;
email: industry.biologics@fda.gov.
For all other investigational drugs, call 301-796-3400 or 1-855-543-3784.
After working hours, call FDA's Emergency Call Center at 866-300-4374 or 301-796-8240.
  1. FDA Form 3674 - Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C., 282(j))

    Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the Public Health Service Act (PHS Act) by adding section 402(j) (42 U.S.C. 282(j)). The new provisions require additional information to be submitted to the clinical trials data bank (ClinicalTrials.gov), including expanded information on clinical trials and information on the results of clinical trials. One new FDAAA provision, 42 U.S.C. 282(j)(5)(B), requires that a certification accompany human drug, biological, and device product submissions made to FDA. At the time of submission of an application under sections 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (21 U.S.C. 262), or submission of a report under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification that all applicable requirements of section 402(j) of the PHS Act have been met. Where available, such certification must include the appropriate National Clinical Trial (NCT) numbers. FDAAA requires that the certifications be submitted to FDA beginning no later than December 26, 2007.

  1. 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
  2. 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.
  3. IND Regulations - Title 21 of the Code of Federal Regulations (CFR), Part 312 (21 CFR 312
  4. Current Good Manufacturing Practice in Manufacturing, Processing, Packaging or Holding of Drugs; General (21 CFR 210)
  5. Current Good Manufacturing Practice for Finished Pharmaceuticals (21 CFR 211)
  6. 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.

  7. 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.
  8. Informed Consent of Human Subjects (21 CFR 50, Subpart B)
  9. Institutional Review Boards (21 CFR 56)
  10. Good Laboratory Practices for Nonclinical Laboratory Studies (21 CFR 58)
  11. Refer to General Guidances and Guidelines, Points to Consider, and Guidances specific to IND submissions.
  12. Good Clinical Practice in FDA-Regulated Clinical Trials
  13. SOPP 8201 - Issuance of and Response to Clinical Hold Letters for Investigational New Drug Applications
  14. SOPP 8202 - Handling INDs Submitted with Insufficient Copies
  15. SOPP 8007 - DCC Binding Procedures for Regulatory Documents
  16. Draft Guidance for Industry and Reviewers: Estimating the Safe Starting Dose in Clinical Trails for Therapeutics in Adult Healthy Volunteers
  17. Information on the Use of Antivenoms

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. 20401, 202-512-0000.

Questions regarding IND submissions may be directed to the Manufacturers Assistance and Technical Training Branch, 800-835-4709 or 240-402-8010.

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