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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 21 Reset Results
Read the report from our public meeting on Leveraging Real-World Treatment Experience from Expanded Access Protocols.
FDA Commissioner Dr. Scott Gottlieb joined CDER Director Dr. Janet Woodcock and CBER Director Dr. Peter Marks to make an important statement about Expanded Access (EA). In short, the message encourages “sponsors...
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...
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.   Sample 1...
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...
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.