Type text, add images, blackout confidential details, add comments, highlights and more.
02. Sign it in a few clicks
Draw your signature, type it, upload its image, or use your mobile device as a signature pad.
03. Share your form with others
Send fda form 3926 via email, link, or fax. You can also download it, export it or print it out.
How to use or fill out FDA Form 3926 with our platform
Ease of Setup
DocHub User Ratings on G2
Ease of Use
DocHub User Ratings on G2
Click ‘Get Form’ to open it in the editor.
In Box 1, enter the patient’s initials and the date of submission. This ensures confidentiality while documenting your request.
For Box 2, provide detailed clinical information including the indication, a brief clinical history (age, gender, weight, allergies), and rationale for requesting treatment. This section is crucial for justifying the need for expanded access.
In Box 3, specify the investigational drug's name and outline the treatment plan. Include details such as dosage, route of administration, duration of treatment, and monitoring procedures.
If applicable, attach a Letter of Authorization (LOA) from the drug manufacturer in Box 4. This allows FDA to reference necessary information regarding the drug.
Complete Box 5 with your qualifications as a physician. You may attach your CV if preferred.
Fill in your contact information in Box 6 to ensure FDA can reach you easily regarding your application.
In Box 7, request authorization to use Form FDA 3926 for compliance with IND submission requirements.
Finally, sign and date Box 8 certifying that you will not begin treatment until receiving FDA notification or after 30 days.
Start using our platform today to streamline your form completion process for free!
Also known as a notice of inspection, the Food and Drug Administration (FDA) Form 482 is an official document presented to the investigator upon arrival at the study site that gives the FDA the authority to access, inspect and copy any required records related to the clinical investigation.
What is a 482 in pharma?
FDA Form 482 is a form used by the Food and Drug Administration (FDA) in the pharmaceutical industry. This form is used to inform the manufacturing site of an audit that is about to take place. This form is also known as a Notice of Inspection (NOI) form. According to Food and Drug Cosmetic Act (FDA) Section No.
What is a FDA form 482?
FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and Notice of Inspection (FDA Form 482) upon arriving at your plant.
What is single patient compassionate use?
The Single Patient Emergency and Compassionate Use mechanisms allow for use of investigational drugs, biologics, or devices to treat or diagnose patients when specific criteria are met. Both types of use are generally intended for the clinical treatment of a single patient.
Who signs the FDA form 482?
Upon arrival at the clinical investigator study site, the FDA investigator will display his/her FDA credentials and issue a completed Form FDA 482 (Notice of Inspection) to the clinical investigator or appropriate study staff.
02 945 3926
FDA Form 3926 instructionsFDA Form 1572FDA Form 1571FDA FormsFDA Form 3331a downloadFDA FORM 3881FDA expanded accessFDA Form 3938
People also ask
What is the FDA form 3926?
If a pharmaceutical company agrees to supply the investigational treatment, the treating physician must next request permission to proceed from the FDA through a form FDA 3926, also known as the Individual Patient Expanded Access Investigational New Drug Application.
What is the difference between emergency use authorization and expanded access?
IRB agreement that a particular case meets FDA criteria for emergency use applies to the treatment of one patient only and is not the same as IRB approval to conduct a research study. Expanded access, sometimes called compassionate use, is the use outside of a clinical trial of an investigational medical product.
form 3926
FORM FDA 3926
I request authorization to submit this Form FDA 3926 to comply with FDAs requirements for an individual patient expanded access IND. 10.a. Request for
This site uses cookies to enhance site navigation and personalize your experience.
By using this site you agree to our use of cookies as described in our Privacy Notice.
You can modify your selections by visiting our Cookie and Advertising Notice.... Read more...Read less
