Expanded Access to Experimental Biologics

Clinical trials are studies of drugs and biologics that are still in development and have not yet been approved by the FDA. Many patients enroll in clinical trials to gain access to investigational therapies and contribute to finding out how well an investigational therapy works, and how safe it is for patients. Obtaining a drug or biologic under an expanded access program may be an option for some patients who are not able to enroll in clinical trials. The FDA has allowed expanded access to experimental drugs and biologics since the 1970s. That access has allowed tens of thousands of patients with HIV/AIDS, cancer, and other conditions to receive promising therapies when no approved alternative is available.

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Videos

• Expanded Access Part 1: Introduction
  An introduction to Expanded Access for investigational medical products
  Transcript: Expanded Access Part 1: Introduction (May 2019)

• Expanded Access Part 2: How to Submit a Single Patient IND
  An overview on the submission process for emergency and non-emergency expanded access applications.
  Transcript: Expanded Access Part 2: How to Submit a Single Patient IND (September 2019)

• Expanded Access Part 3: How to Complete Form FDA 3926 for Initial Submissions
  Provides instructions on completing Form FDA 3926, a one-page form, front and back for initial submissions.
  Transcript: Expanded Access Part 3: How to Complete Form FDA 3926 for Initial Submissions (September 2019)

• Expanded Access Part 4: How to Complete Form FDA 3926 for Follow-up Submissions
  Provides instructions on completing Form FDA 3926 for follow-up submissions.
  Transcript: Expanded Access Part 4: How to Complete Form FDA 3926 for Follow-up Submissions (September 2019)

 

Emergency Requests

If there is an emergency that requires the patient to be treated before a written submission can be made, FDA may allow the treatment use to proceed without a written submission, provided the applicable criteria are met. In an emergency situation, the request to use the drug may be made via telephone, fax, or other means of electronic communication, and authorization to ship and use the drug may be given by the FDA official over the telephone.

During normal business hours (8 am – 4:30 pm EST weekdays)

• For investigational biological products regulated by CBER call 240-402-8020 or 800-835-4709; or
  e-mail: industry.biologics@fda.hhs.gov.
• For all other investigational drugs, call 301-796-3400 or 855-543-3784

After hours (after 4:30 pm EST weekdays and all day on weekends)

• All questions about and requests for expanded access for emergency use for drugs, biologics and medical devices should be directed to the FDA Emergency Call Center, telephone: 866-300-4374 or 301-796-8240.

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Key Resources

• Expanded Access (Compassionate Use)
• CBER Expanded Access Submission Receipt Reports
• Development & Approval Process (CBER)