Individual Patient Expanded Access IND Application
This file contains the FDA Form 3926 for Individual Patient Expanded Access Investigational New Drug Applications. It serves as a guide for physicians to submit necessary information for patient access to investigational drugs. This form is crucial for ensuring compliance with FDA regulations.
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How do I fill this out?
To fill out this form, begin by entering the physician's contact information, including name and institution. Next, specify the patient's initials and the type of submission, whether it's an initial or follow-up submission. Lastly, provide the clinical information and details about the investigational drug.
How to fill out the Individual Patient Expanded Access IND Application?
1
Enter the physician's information.
2
Specify the patient's initials.
3
Select the type of submission.
4
Fill in clinical and treatment information.
5
Sign and date the form.
Who needs the Individual Patient Expanded Access IND Application?
1
Physicians seeking investigational drugs for patients.
2
Clinical researchers needing FDA approval for treatments.
3
Healthcare providers managing patient care with limited options.
4
Drug manufacturers looking to facilitate expanded access.
5
Institutional Review Boards overseeing treatment use.
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What are the instructions for submitting this form?
To submit this form, you may send it electronically via email to the FDA review division if applicable. You can also fax the completed form to the relevant FDA office, or mail it to the physical address listed on the form. Remember to keep a copy for your records and ensure all required fields are filled out before submission to avoid delays.
What are the important dates for this form in 2024 and 2025?
Key dates for this form include the approval expiration date of October 31, 2026. Ensure timely submissions and renewals prior to this date. It is recommended to stay informed about any updates from the FDA regarding this form.
What is the purpose of this form?
The purpose of this form is to facilitate access to investigational drugs for patients who have serious or life-threatening conditions. It allows physicians to provide necessary information for the FDA to evaluate and potentially approve expanded access. This ensures that patients have access to promising therapies when no alternatives are available.
Tell me about this form and its components and fields line-by-line.
- 1. Physician Details: Includes name, institution, address, and contact information.
- 2. Patient's Initials: Initials of the patient requesting the investigational drug.
- 3. Type of Submission: Indicates whether it's an initial or follow-up submission.
- 4. Clinical Information: Details about the patient's medical history and current status.
- 5. Treatment Information: Information on the investigational drug and treatment plan.
- 6. Certification Statement: A statement confirming compliance with FDA requirements.
What happens if I fail to submit this form?
Failure to submit this form can result in delays in obtaining investigational drugs for your patients.
- Delay in Treatment: Patients may face a postponement in receiving necessary medical care.
- Regulatory Issues: Non-compliance with FDA regulations can lead to legal ramifications.
- Inaccessibility of Drugs: Without submission, patients may not gain access to critical investigational therapies.
How do I know when to use this form?
- 1. Initial Patient Access: To request initial use of an investigational drug for a patient.
- 2. Follow-Up Requests: When submitting follow-up documents for ongoing patient treatment.
- 3. Emergency Situations: If a patient requires immediate access to a treatment not yet approved.
Frequently Asked Questions
What is FDA Form 3926?
FDA Form 3926 is used for Individual Patient Expanded Access Investigational New Drug Applications.
Who should fill out this form?
Physicians and healthcare providers seeking investigational drugs for patients should fill out this form.
How do I submit the form?
Once completed, you can submit the form via email, fax, or physical mail as directed on the document.
Can I edit this PDF?
Yes, you can edit this PDF directly on PrintFriendly before downloading.
Is it possible to sign this document electronically?
Yes, PrintFriendly allows you to sign the PDF electronically.
What if I encounter issues with this form?
If you have issues, consult the form instructions or contact FDA support for assistance.
Can I share my filled PDF?
Absolutely! You can share your filled PDF through various platforms using PrintFriendly.
What fields are required in this form?
The form requires the physician's information, patient details, treatment plan, and clinical information.
How long does it take to fill out the form?
It typically takes around 45 minutes to complete the form, ensuring all details are filled accurately.
What happens after I submit this form?
After submission, the FDA will review your application to ensure compliance and may contact you for clarifications.
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