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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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CDER's Office of Communication, Division of Drug Information shares "FDA Oncology Center of Excellence’s Project Facilitate: An Overview of the Oncology Expanded Access Program," an expanded access webinar...
New 4-part FDA Drug Info Rounds video series for physicians detailing how to submit single-patient expanded access requests for investigational drugs and biologics.
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...
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...
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...