Resources

Expanded Access eRequest allows physicians and other prescribers to request non-emergency use of medical products for patients. The app allows physicians to complete, sign, and submit Form 3926 online to FDA. 

Active clinical trialA trial open for enrollment of patientsActive, not recruiting (clinical trial)The study is ongoing but new participants are not currently being enrolledAdverse eventA medical problem that happens during treatment with a drug or other therapy, which may be mild, moderate, or…

This guidance provides recommendations to institutional review boards (IRBs) and clinical investigators regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of the IRB, to…

Expanded Access to Investigational Drugs for Treatment Use Questions and Answers Guidance for Industry

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. Read FDA's Guidance for IRBs and…

Find answers and hear a family’s experience with Expanded Access in this new “Patients Matter” video from FDA.

Project Facilitate assists medical professionals seeking expanded access for patients with cancer FDA's Oncology Center for Excellence is piloting Project Facilitate to provide continuous support to oncology physicians and other healthcare professionals throughout the expanded access process.

Image Read the report from our public meeting on Leveraging Real-World Treatment Experience from Expanded Access Protocols.

Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period. Therapeutic Innovation & Regulatory Science, 50(6), 705–709. Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring…

The initial IND submission and each subsequent submission to the IND should be accompanied by a Form FDA 1571. See Form FDA 1571 submission details here.   

These sample policies may be useful to companies developing expanded access policies. Companies can post their policies or a link to their policies in the EA Navigator Company Directory.

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 Single Patient Request, this request process is a potential pathway for access to…

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 clinicaltrials.gov. Presenters for this event included Foundation Executive Director June Wasser…

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.Download PDF

Q&A document from FDA outlines October 2017 updates to Guidance on Expanded Access to Investigational Drugs for Treatment Use.

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.

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 trial’s sponsor or principle investigator.

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 requirements that apply to clinical trials (21 CFR 312.32) apply to expanded access to the…

Dr. Pazdur, Director of Oncology Center of Excellence at the FDA discusses the Expanded Access process

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 the pharmaceutical company, the FDA, or the IRB.

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 process. You can also download and print EA forms listed in the Navigator’s…

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 criteria on which FDA bases its review of a new drug. While the primary intent of…

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. It’s crucial to be aware of and acknowledge the role and perspective of each party…

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 druginfo@fda.hhs.gov. To request emergency access to investigational…