Get Fda 3926 2017-2025

This guide provides a clear and comprehensive overview of how to fill out Form FDA 3926 for individual patient expanded access applications. Designed for licensed physicians seeking to submit requests for investigational drugs, this guide aims to assist users with varying levels of familiarity with regulatory forms.

Follow the steps to complete Form FDA 3926 online effectively.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Carefully read the instructions provided with the form to understand the requirements for submission.
3. Fill out the patient information section, including the patient's name, contact details, and relevant medical history.
4. Complete the physician's information section, ensuring to provide your credentials, contact information, and any relevant licenses.
5. In the treatment information section, detail the investigational drug being requested, including the indication for use, dosage, and any pertinent treatment history.
6. Check the box in Field 10.a to request a waiver for any additional requirements, which indicates that you understand and accept the responsibilities of the application process.
7. If applicable, include any additional documentation, such as a Letter of Authorization from the IND holder, to support your request.
8. Review the completed form thoroughly to ensure all sections are filled in accurately and completely.
9. Once satisfied, save your changes and download the form for your records.
10. Finally, print or share the form as required for submission to the FDA.

Begin the process of submitting your expanded access application online today.