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Scroll down the resource list below to find user guides, videos, tips and helpful checklists. Some resources contain links to forms anyone can read and download but only physicians can submit. If you are looking for a specific form or topic, type it in the search bar below.

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Displaying 10 of 12 Reset Results
This Q&A document from FDA outlines October 2017 updates to Guidance on Expanded Access to Investigational Drugs for Treatment Use. It covers waivers for convened IRB meetings, addresses how the FDA reviews...
Expanded access can be an option for patients with serious or life-threatening diseases, who have exhausted all FDA-approved treatments, to access investigational products. If you are a patient, caregiver, or...
Contact Information | 1 minute read
If your patient is in an emergency situation where access is needed in a matter of hours or days, physicians should contact the FDA directly through its Division of Drug Information at 855-543-3784 or ...
Filing an IND safety report | 1 Minute Read
Serious and unexpected adverse events must be reported to FDA. This link provides guidance on reporting or you can download an IND safety report Form FDA 3500A for non-emergency Expanded Access. The same...
Form FDA 3926 | 1 Minute Read
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...
Submitting a request for single-patient expanded access requires the involvement of physicians, patients, the Food and Drug Administration (FDA), Institutional Review Boards (IRBs) and pharmaceutical companies....
When discussing possible participation in a clinical trial, it is important to have all the information you need to make a decision. Here are some questions you, or your physician, might want to ask the clinical...
When discussing the possible use of an investigational treatment, it is important to have all the information needed to make a decision. Here are some questions you may ask your physician to ensure you understand the...
If single-patient expanded access (EA) is permitted for a patient, the sponsoring physician is required to comply with FDA reporting requirements during and after the treatment. Clinical trial outcomes are primary...