Drugs

For Physicians: A Guide to Non-emergency Single Patient Expanded Access Submissions

Initiate Expanded Access

Action

Descriptions and Further Information

  1. Request Letter of Authorization

 

  • Request a Letter of Authorization (LOA) from the pharmaceutical company that makes the investigational drug you wish to obtain. A LOA grants the right of reference to the information contained in the supplier’s existing Investigational New Drug (IND) application. If a LOA is not available, submit sufficient information for FDA to assure the product’s quality. A Letter of Authorization template is available from FDA.
  1. Submit Form FDA 3926
  • Instructions for filling out Form FDA 3926 are available online.
  • Submit Form FDA 3926 (along with the LOA) to FDA. You may submit via mail, fax, or e-mail. Further instructions and help about how to submit available online.
  1. Obtain IRB approval
  • Obtain IRB approval per 21 CFR Part 56.

 

  1. Obtain Informed Consent
  • Obtain Informed Consent from patient or their legally authorized representative per 21 CFR Part 50.
  • Use a written consent form approved by the IRB.

Follow-up Submissions (use Form FDA 3926)

Action

Timeframe

Descriptions and Further Information

Safety Reports

As soon as possible

  • Report unexpected fatal or life-threatening suspected adverse reactions to FDA as soon as possible but in no case later than 7 calendar days after the sponsor’s initial receipt of the information.
  • Report serious and unexpected suspected adverse reactions to FDA as soon as possible but in no case later than 15 calendar days after determining that the information qualifies for reporting.
  • Review the Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies.
  • See 21 CFR 312.32 for further information on mandatory safety reporting.

Amendments

Any time

  • Submit protocol and information amendments to FDA for any changes to the initial Expanded Access IND submission per 21 CFR Part 312 (312.30 and 312.31).

Summary

Following completion of treatment

  • When treatment is complete, submit a summary of expanded access use per 21 CFR 312.310(c)(2).

Annual Report

Within 60 days of the anniversary date

  • Submit an annual report within 60 days of the anniversary date that the Expanded Access IND went into effect per 21 CFR 312.33.
  • The Annual Report is not required if treatment was completed and FDA was notified before one year passed.

Search for citations of Title 21 in the Code of Federal Regulations (21 CFR) online at the Electronic Code of Federal of Regulations

Questions?

Contact the Division of Drug Information
(855) 543-3784 or (301) 796-3400 or druginfo@fda.hhs.gov 

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Page Last Updated: 08/11/2017
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