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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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The process for obtaining single-patient expanded access (EA) has several steps and documents to organize. This checklist offers a brief overview of the documents a licensed physician must fill out or obtain from...
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...
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...
This 1-hour long webinar was designed to assist patient advocates in their exploration of potential pre-approval access options and featured the Foundation’s Expanded Access Navigator program and NIH’s...
Active clinical trial A trial open for enrollment of patients Active, not recruiting (clinical trial) The study is ongoing but new participants are not currently being enrolled Adverse event A medical problem that...
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...
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...
If you are a patient, caregiver, or physician looking for investigational therapy options available through either clinical trials or expanded access, you can begin to research and identify them on ...