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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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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 can refer to these sample policies as templates when developing their own expanded access policies to post in the EA Navigator Company Directory.   Sample 1  |  Sample...
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...
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.    Form 1571 and instructions for...
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...
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...