Expanded Access Company Directory Submission Form

All submissions must be reviewed by Foundation staff before they are added to the Company Directory. You will receive an email from the Foundation once your submission has been approved and posted on our Company Directory. If you would like to edit or update an existing entry, please contact us at navigator@reaganudall.org.

Please make your company’s contact information and policy/process/criteria is readily available to physicians requesting single-patient expanded access by completing this form as completely as possible. Fields with asterisks will be displayed on the populated Directory, all other fields only display if the submitting company provides the descriptions requested. The Reagan-Udall Foundation for the FDA will test the functionality of company-provided links before adding a company to the Directory. The Foundation reserves the right not to publish your company's entry if we cannot verify the information or insufficient information is provided.

Company Name

Please provide public-facing contact information for EA inquiries below.

Phone Number

Please use numerals or leave blank if not applicable

Please provide a link to your company's main webpage on EA.

Describe your company's single-patient EA policies and criteria.

What is the anticipated length of time necessary to acknowledge receipt of a request?

Please provide a link to any disease/category specific EA policy page/PDF

If applicable, provide a link to a page or PDF that offers more detailed information than your main EA webpage

Please provide a list of your company's therapies available via single-patient EA. You may also include the therapeutic indication for each.

Please provide a link to your company's records in ClinicalTrials.gov.

Please provide a link to your company's available clinical trials in ClinicalTrials.gov. If you do not know how to provide such a link, please leave blank and we will provide on your behalf.

If you need to update information previously submitted, please contact the Foundation directly at navigator@reaganudall.org or call (202) 849-2075.

In order to verify this information and ensure it stays up to date, the Foundation will need a specific point of contact at your company. This information will remain private and not be published on the EA Navigator website. By providing us this contact information, you are giving us permission to provide you with occasional updates from the Reagan-Udall Foundation to the FDA.

Name

Phone Number

Please use numerals or leave blank if not applicable

If applicable, please provide an alternative point of contact.

Name

Phone Number

Please use numerals or leave blank if not applicable

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Expanded Access Company Directory Submission Form

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