Get the free Individual Patient Expanded Access Applications: Form FDA 3926; Draft Guidance for I...

WWW.LOS.org April 13, 2015, Division of Dockets Management US Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 RE: Docket No. FDA2015D02680001 Individual Patient Expanded

How to fill out individual patient expanded access

How to fill out individual patient expanded access:

1. First, gather all relevant medical information of the patient, including their medical history, current condition, and any other pertinent details.
2. Consult with the patient's healthcare provider or primary physician to discuss the potential benefits and risks of participating in an individual patient expanded access program.
3. Contact the pharmaceutical company or sponsor overseeing the expanded access program to inquire about their specific process and requirements for application.
4. Obtain the necessary forms or documentation from the pharmaceutical company or sponsor, which may include consent forms, medical release forms, and any other required paperwork.
5. Complete all sections of the forms accurately and honestly, providing detailed information about the patient's condition, treatment history, and any previous therapies or medications tried.
6. Attach any supporting documents or medical records that may be requested, such as test results, specialist consultations, or imaging scans.
7. Ensure that all required signatures are obtained from both the patient and their healthcare provider, acknowledging their understanding and agreement to participate in the expanded access program.
8. Review the completed forms and documentation for accuracy and completeness before submitting them to the pharmaceutical company or sponsor.
9. Follow up with the pharmaceutical company or sponsor to confirm receipt of the application and inquire about the next steps in the process.
10. Continually communicate with the patient's healthcare provider and the pharmaceutical company or sponsor throughout the application process for any updates or additional information needed.

Who needs individual patient expanded access?

1. Patients who have exhausted all available treatment options for their condition and have not responded adequately to standard therapies may need individual patient expanded access.
2. Individuals who have a life-threatening or serious condition for which there are no approved treatment options may also require individual patient expanded access.
3. Patients who meet specific eligibility criteria set by the pharmaceutical company or sponsor overseeing the expanded access program may be eligible for individual patient expanded access.

For pdfFiller’s FAQs

What is individual patient expanded access?

Individual patient expanded access allows patients with serious or life-threatening conditions to access investigational drugs outside of a clinical trial.

Who is required to file individual patient expanded access?

The patient's physician is required to file for individual patient expanded access on behalf of the patient.

How to fill out individual patient expanded access?

The physician must fill out the necessary forms and submit them to the FDA for review.

What is the purpose of individual patient expanded access?

The purpose of individual patient expanded access is to provide patients with access to investigational drugs that may not be otherwise available to them.

What information must be reported on individual patient expanded access?

Information such as the patient's medical history, the drug being requested, and the reason for the request must be reported on individual patient expanded access.

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