Get the free Individual Patient Expanded Access Applications: Form Fda 3926
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This guidance provides an overview of Form FDA 3926 for individual patient expanded access to investigational drugs, detailing the application process and regulatory requirements.
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What is individual patient expanded access?
Individual patient expanded access is a regulatory mechanism that allows a physician to request access to an investigational drug for a patient with a serious or life-threatening condition who does not have other treatment options available.
Who is required to file individual patient expanded access?
The physician treating the patient is required to file for individual patient expanded access and must obtain approval from the regulatory authority as well as inform the drug manufacturer.
How to fill out individual patient expanded access?
To fill out an individual patient expanded access request, a physician must complete a submission form detailing the patient's medical history, condition, how the investigational drug might benefit the patient, and any previous treatment attempts.
What is the purpose of individual patient expanded access?
The purpose of individual patient expanded access is to provide patients with serious or life-threatening conditions access to investigational drugs when they have no other treatment options and when participation in clinical trials is not feasible.
What information must be reported on individual patient expanded access?
The information that must be reported includes patient demographics, medical history, the nature of the condition, details about prior treatments, and how the investigational drug will be used.
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