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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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For patients with serious or life threatening disease who have exhausted all available treatments and are not eligible for a clinical trial, Expanded Access may be an option. Also known as Compassionate Use or...
CDER's Office of Communication, Division of Drug Information is now offering their " FDA Drug Topics: An Overview of FDA's Expanded Access Program with a Focus on Individual Patient Expanded Access" as a Home...
In October 2017, FDA released a six-page, Information Sheet Guidance for sponsors, clinical investigators and IRBs on the Waiver of IRB requirements for Drug and Biological Product Studies.
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...
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...
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...