Administrative Modules and Submission of IND Application

The administrative module of an IND application includes essential forms and information that provide the FDA with details about the sponsor, the investigational drug, and the proposed clinical trials. Key components include:

1. Form FDA 1571: The Investigational New Drug Application form, which includes information about the sponsor, the investigational drug, and the clinical trials.
2. Form FDA 1572: The Statement of Investigator form, which provides information about the principal investigator conducting the clinical trial.
3. Cover Letter: A cover letter that summarizes the contents of the IND application and highlights any critical information or requests.
4. Investigator’s Brochure: A document that provides clinical and non-clinical data on the investigational drug to the investigators conducting the clinical trials.

Submission

The submission of an IND application involves several steps to ensure that the FDA receives all necessary information to review the investigational drug’s safety and efficacy:

1. Electronic Submission: The FDA encourages electronic submission of IND applications through the Electronic Submissions Gateway (ESG).
2. Submission Format: The IND application should be organized according to the Common Technical Document (CTD) format, which includes modules for administrative information, quality, non-clinical, and clinical data.
3. Submission Checklist: A checklist to ensure that all required components are included in the IND application.

Read also:

• Types of FDA Applications for Drugs and Biologics
• Types and Components of Investigational New Drugs (IND) Application
• Differences in Filing for Drug Master File in US, Canada and Europe