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IRB Administration Office 87 E. Canfield, Second Floor Detroit, MI 48201 (313) 5771628 IRB. Wayne.single Patient Expanded Access Submission Form This form is to be completed when there is a single
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How to fill out single patient expanded access
How to fill out single patient expanded access
01
Obtain approval from the treating physician to pursue single patient expanded access.
02
Contact the pharmaceutical company or sponsor of the drug to request access to the medication.
03
Submit an individual patient expanded access request to the FDA, including all required documentation and justification for the request.
04
Await approval from the FDA before administering the medication to the patient.
05
Monitor the patient closely for any adverse reactions or side effects while they are receiving the medication.
Who needs single patient expanded access?
01
Patients who have exhausted all other treatment options and have a serious or life-threatening condition for which there are no alternative therapies available may be eligible for single patient expanded access.
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What is single patient expanded access?
Single patient expanded access is a pathway that allows a physician to request access to an investigational drug, biologic, or medical device for a single patient.
Who is required to file single patient expanded access?
The physician overseeing the care of the patient is required to file for single patient expanded access.
How to fill out single patient expanded access?
To fill out single patient expanded access, the physician needs to complete the necessary forms and submit them to the appropriate regulatory authority.
What is the purpose of single patient expanded access?
The purpose of single patient expanded access is to provide access to investigational treatments for patients who have exhausted all other treatment options.
What information must be reported on single patient expanded access?
The physician must report information such as the patient's medical history, the rationale for seeking the investigational treatment, and any potential risks or benefits.
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