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 In this section:

                Development & Approval Process (CBER)

Development & Approval Process (CBER)

                        2023 Biological Approvals
          2022 Biological Approvals
          Biological Approvals by Year
          Expanded Access to Experimental Biologics
          Vaccine Development – 101


                        Biologics License Applications (BLA) Process (CBER)
          Investigational New Drug Applications (INDs) for CBER-Regulated  Products
          Device Submissions for CBER-Regulated Products
          Labeling for CBER-Regulated Products
          Master Files for CBER-Regulated Products
          New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
          Formal Meetings for CBER-Regulated Products Home
          Vaccines, Blood & Biologics
          Development & Approval Process (CBER)
          Expanded Access to Experimental BiologicsDevelopment & Approval Process (CBER) Expanded Access to Experimental Biologics
  
  	
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    PrintClinical 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.

**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.

Key Resources

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

                                                                                  Content current as of:
      09/16/2019
              
              
Regulated Product(s)
		 BiologicsTopic(s)
			  Consumer HealthDevelopment & Approval Process (CBER)

          
                        2023 Biological Approvals
          2022 Biological Approvals
          Biological Approvals by Year
          Expanded Access to Experimental Biologics
          Vaccine Development – 101


                        Biologics License Applications (BLA) Process (CBER)
          Investigational New Drug Applications (INDs) for CBER-Regulated  Products
          Device Submissions for CBER-Regulated Products
          Labeling for CBER-Regulated Products
          Master Files for CBER-Regulated Products
          New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
          Formal Meetings for CBER-Regulated Products
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