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How to fill out the Access Applications: online
This guide provides a detailed walkthrough for completing the Access Applications using Form FDA 3926. Designed for licensed physicians seeking expanded access for individual patients, this guidance aims to facilitate the submission process for investigational drugs through an online format.
Follow the steps to effectively complete the Access Applications online.
- Press the ‘Get Form’ button to retrieve the Access Applications form and open it for editing.
- Begin by entering patient information in the specified fields. This includes the patient's full name, contact information, and details regarding their medical condition.
- Provide information about the investigational drug requested. Specify the drug name, dosage, and the reason for seeking expanded access.
- Fill out the risk assessment section where you evaluate the potential benefits of the investigational drug against its risks for the patient.
- Include a cover letter explaining the rationale for the request, detailing how the criteria for expanded access are met, such as the seriousness of the disease and lack of alternatives.
- Complete the required fields regarding the physician’s information, including their qualifications and contact details.
- Review all provided information for accuracy and completeness before submitting the form.
- After ensuring the form is correctly filled, you can save changes, download, print, or share the form as needed.
Take the next step towards securing access for your patient by completing the Access Applications online.
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