| Content | Description |
| Cover Letter (typically 1 page or less) | -Submission Identifier: “Initial Investigational New Drug Application” -Brief explanation of the intended investigation (type and title of study) -Investigational new drug product’s name and proposed formulation -Disease or condition under investigation -IND manufacturer’s name and contact information (if applicable) -Reference to an existing IND application (if applicable) The Cover Letter is typically addressed to the Director of the Review Division in the Office of New Drugs and signed by the sponsor of the IND application. |
| Form 1571 | Administrative information |
| Form 1572 | Statement of the Investigator, must be submitted for each Investigator participating in a clinical study. |
| Form 3674 | Certification of compliance with requirements of ClinicalTrials.gov Data Bank |
| Table of Contents | The Table of Contents for IND application is expected to be detailed enough to permit FDA reviewers to locate items in the application quickly and easily. |
| Introductory Statement and General Investigational Plan (typically 2-3 pages) | Place the clinical development plan for the Investigational New Drug into perspective and to help FDA anticipate the needs of the program. |
| Chemistry, Manufacturing, and Control Information | Drug substance/product. Labeling & Environmental Assessment To address any possible human risks. How these safety issues will be addressed. Any differences between the clinical and animal toxicology batches. |
| Pharmacology Toxicology Information | To support the safety of the proposed clinical investigations. Compliance with Good Laboratory Practice (GLP) is generally expected for pivotal in vitro and in vivo studies submitted. If the study was not conducted in compliance with the GLP regulations, investigators should submit a brief statement of the reason for noncompliance. Pharmacology and Drug Disposition- description of the pharmacological effects and the mechanisms of action of the drug in animals and information on the absorption, distribution, metabolism, and excretion of the investigational product, if known. Toxicology- the toxicological effects of the drug in animals and in vitro. For each toxicological study that is intended primarily to support the safety of the proposed clinical investigation, a full tabulation of data suitable for detailed review is expected. This should consist of line listings of the individual data points, including laboratory data points for each animal along with appropriate summary tabulations. |
| Investigator’s Brochure | Investigators may obtain Investigator’s Brochure (IB) from IND product’s manufacturer, is expected to contain the following information: -Brief description of the drug substance and the formulation, including the structural formula, if known -Summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans -Summary of the pharmacokinetics and biological disposition of the drug in animals and, if known, in humans -Summary of information relating to safety and effectiveness in humans obtained from prior clinical studies -Description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or with related drugs, and of precautions or special monitoring to be done as part of the investigational use of the drug. Adverse Events (AEs) described in the IB help determine whether an AE that occurs during a clinical trial is “expected” and, if so, how it will be reported to FDA. |
| Clinical Protocol(s) | Clinical Protocol should be submitted for each planned clinical study or trial. An original IND application submission lacking a clinical protocol is considered incomplete. Protocols for subsequent studies not submitted with the original IND application can be submitted at a later time as Protocol Amendments. |
| Informed Consent | The sponsor should include a copy of the informed consent document in the original IND submission. |
| Summary of Previous Human Experience with the Investigational Drug | NA for individualized ASOs. |
More details can be found in the FDA webpage.