IND Annual Report Template: - DF/HCC



IND Content and Format Checklist

A sponsor who intends to conduct a clinical investigation with an investigational new drug/biologic that is subject to 312.2(a) must submit an Investigational New Drug Application (IND). Detailed information can be found on the FDA website, Code of Federal Regulations, 21 CFR 312 (). An outline of the contents is provided below:

|Cover Letter |Included |

|Transmittal letter introducing original IND submission | |

|Cover Sheet (FDA 1571) | |

|FDA Form 1571 | |

|Table of Contents | |

|There is no standard format for the table, however FDA requires that the format be “in the interest of | |

|fostering an efficient review of the application” | |

|Introductory Statement and General Investigational Plan | |

|This section should be brief, no more than three pages. The statement should provide a description of the | |

|drug and the goals of the proposed investigations. Specific elements should include: | |

|i) A brief statement describing the drug, broad objectives, and planned duration of the proposed clinical | |

|investigation | |

|ii) A brief summary (if applicable) of previous human experience with the drug | |

|iii) If the drug has been withdrawn from investigation or marketing in any country, explain reasons for | |

|withdrawal | |

|iv) A brief description of the overall plan for investigating the drug product for the following year. | |

|This may include: rational for study, indication(s) to be studied, general approach, types of clinical | |

|studies, target enrollment, and any anticipated risks | |

|Investigator’s Brochure | |

|An investigator’s Brochure may be obtained from the drug manufacturer or referenced in a Letter of | |

|Authorization (see note below). | |

|For guidance on writing an Investigator’s Brochure, see ICH GCP Efficacy Guidelines – E6 | |

|( ) | |

|i) A brief description of the drug substance and formulation | |

|ii) Summary of the pharmacological and toxicological disposition of the drug in animals and in humans (if | |

|known) | |

|iii) Summary of safety and efficacy in humans obtained from prior clinical studies | |

|iv) A description of risk and side effects based on prior experience with the drug under investigation or | |

|with related drugs, and any special monitoring required as part of investigational use of the drug | |

|Protocol(s) | |

|Include a protocol for each planned clinical study (Protocols for studies not incorporated into the initial | |

|submission of the IND application should be subsequently submitted as a Protocol Amendment | |

|Format: | |

|DF/HCC Biomedical Protocol Template (located in the Clinical Investigator Toolkit) | |

|FDA Form 1572 for each clinical site conducting the protocol | |

|A sample Informed Consent Form (if available) | |

|FDA Form 3674 ( certification) for each applicable clinical trial | |

|Chemistry, Manufacturing and Control Information | |

|The CMC section should describe the composition, manufacture, and control of the drug substance and the drug | |

|product. Information included in this section should assure the proper identification, quality, purity, and | |

|strength of the investigational drug. | |

| | |

|Information regarding the Chemistry, Manufacturing, and Control section may be obtained from the drug | |

|manufacturer or referenced in a Letter of Authorization (see note below). | |

|i) Description of the drug substance | |

|ii) Description of the drug product | |

|iii) Description of any placebo used in the studies | |

|v) Specify any environmental analysis performed on investigational product or indicate a claim for exclusion | |

|under 21 CFR 25.30 or 21 CFR 25.31 | |

|Pharmacology and Toxicology Information | |

|The section should include information about pharmacological (no more than 5 pages) and toxicological studies (no| |

|more than 15 pages) involving laboratory animals or in vitro, on the basis of which the sponsor has concluded | |

|that is reasonably safe to conduct the proposed clinical investigations. | |

| | |

|Information regarding the Pharmacology and Toxicology section may be obtained from the drug manufacturer or | |

|referenced in a Letter of Authorization (see note below). | |

|i) Pharmacology and drug disposition | |

|ii) Toxicology | |

|iii) A statement that the study was conducted in compliance with GLP regulations as outlined in 21 CFR 58 | |

|Previous Human Experience with the Investigational Drug | |

|The section should indicate whether the investigational drug, or any of its active ingredients, has been marketed| |

|or tested in humans previously. Include the following: | |

|i) A summary of previous human experience known to the sponsor | |

|ii) If drug is combination product, a summary of previous human experience for each active drug component | |

|iii) A listing of countries in which the drug has been marketed and a listing of countries in which the drug has | |

|been withdrawn from marketing for reasons potentially related to safety or effectiveness | |

|Additional Information | |

|i) DF/HCC Institutional Data and Safety Monitoring Plan (located on the QACT website) | |

|ii) Letter of Authorization to Cross-Reference (if applicable) | |

|iii) Certificate of Analysis (if applicable) | |

|iii) A copy of all labels that will be assigned to the drug product and if applicable, all labels that will be | |

|provided to each investigator. See 21 CFR 312.6 for labeling requirements. | |

|iv) Information regarding drug dependence and abuse potential (if applicable) | |

|v) If the drug is radioactive, data from animal or human studies used for justifying acceptable absorbed | |

|radiation calculation dose for human subjects (if applicable) | |

|vi) Plans for assessing pediatric safety and effectiveness (if applicable) | |

FDA Forms 1571, 1572 and 3674 along with completion instructions can be located at:



DevelopedandApproved/ApprovalApplications/InvestigationalNewDrugIND

Application/ucm071098.htm

Letter of Authorization:

A letter of authorization is an authorization that the manufacturer is allowing FDA to refer to their IND or marketing application in providing the technical information supporting the proposed clinical investigation. The letter of authorization can be used for the Investigator’s Brochure, Chemistry, Manufacturing and Controls, and the Pharmacology and Toxicology sections of the IND. Please note, it is recommended that the Sponsor-Investigator and any site PIs have a copy of the Investigator’s Brochure as a reference throughout the clinical trial. A sponsor-investigator submitting an IND not subject to a manufacturer's IND or marketing application is ordinarily required to submit all technical information, unless such information may be referenced from the scientific literature. (312.22 (d))

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