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4.8 out of 5

150 votes

The document provides guidance on the use of Form FDA 3926 for Individual Patient Expanded Access Applications, allowing licensed physicians to request access to investigational drugs for patients with serious or life-threatening conditions when no satisfactory alternatives exist. It outlines the criteria, regulatory requirements, and procedures for submitting requests, including emergency situations. The guidance emphasizes patient safety while facilitating access to investigational treatments and includes updates on IRB review requirements.

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Click ‘Get Form’ to open it in the editor.
Begin by filling out the patient information section, ensuring all details are accurate and complete. This includes the patient's name, date of birth, and medical history relevant to the investigational drug.
In the next section, provide details about the investigational drug being requested. Include its name, dosage, and any previous treatments attempted for the condition.
Complete the physician's information section. Ensure that your credentials and contact information are clearly stated for verification purposes.
Review all sections for accuracy. Utilize our platform’s editing tools to make any necessary adjustments before finalizing your submission.
Once satisfied with the form, sign it electronically within our editor and submit it directly through our platform for processing.

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Versions	Form popularity	Fillable & printable
2017	4.8 Satisfied (150 Votes)
2015	4.4 Satisfied (480 Votes)

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