Prepare the Initial IND Submission

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The IND Sponsor-Investigator compiles information in three broad areas:

  • Animal Pharmacology and Toxicology Studies: Preclinical data used to assess whether the product is reasonably safe for studies in humans. For studies of marketed drugs in new indications, this section might contain data from animal models supporting the utility of the drug in the new indication.
  • Manufacturing Information: The composition, stability, and controls used for manufacturing the drug substance and the drug product. For marketed drugs, the FDA already has this information on file in the manufacturer’s Drug Master File (DMF). An Investigator-Sponsor can request a Letter of Authorization (LOA) from the manufacturer to refer to the information, although it is not required. For legally marketed drugs, the information in the product label or package insert might suffice for the manufacturing information.
  • Clinical Protocols and Investigator Brochures: A detailed clinical study protocol, and Investigator Brochure are required sections of an IND application. The Investigator Brochure is primarily needed for multi-center studies and is a summary of information needed by participating investigators to assess the safety of the investigational product. For approved medications, a copy of the Prescribing Information may be used in place of an Investigator Brochure.

The IND Sponsor-Investigator writes the IND in the format of IND Application Template. The initial IND submission should be accompanied by a cover letter, an IND Application Form - FDA 1571 (see instructions) and a Certification of Compliance - FDA 3674.

The IND Sponsor-Investigator must also submit a Statement of Investigator - FDA Form FDA 1572 (see instructions). This form is a formal contract with FDA to adhere to Informed Consent, IRB review, and general IND regulations.

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