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                Expanded Access

Expanded Access

                        Expanded Access | Information for Patients
          Expanded Access | Information for Physicians
          Expanded Access | Information for Industry
          Expanded Access | How to Submit a Request (Forms)
          Expanded Access | Keywords, Definitions, and Resources
          Expanded Access (Compassionate Use) Submission Data
          FDA's Expanded Access Contact Information Home
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          Expanded Access
          Expanded Access | Information for PhysiciansExpanded Access Expanded Access | Information for Physicians
  
  	
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**On this page, you will find information about:**

What is expanded access?
	Keywords, definitions, and resources
	What are the roles and responsibilities?
	What are the different types of expanded access?
	What is the licensed physician’s role in the expanded access process?
	What are the reporting requirements for Sponsor-Investigators of expanded access?
	How do Sponsor-Investigators submit expanded access requests and reports to FDA?
	Additional resources

**Learn About Keywords, Definitions, and Resources**

What is expanded access?

Image of an elderly man being handed documents by a female nurse
**On average, FDA determines that the vast majority of all expanded access requests may proceed.**

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

When seeking expanded access to an investigational medical product, it is critical that the patient and his/her licensed physician consider all possible risks. Investigational medical products have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.

Investigational medical products include investigational new drugs and biologics, and investigational devices. Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms “investigational drug” and “investigational new drug” are deemed to be synonymous. Investigational device means a device, including a transitional device, that is the object of an investigation. This means that these products have not yet been approved by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.

Whenever possible, an investigational medical product should be used as part of a clinical trial. However, if patient enrollment is not possible (e.g., patient ineligibility, lack of ongoing clinical trials), or enrollment in a clinical trial is not feasible (e.g., distance to a trial precludes access), expanded access offers a possible route for gaining access to an investigational medical product.

FDA is committed to increasing awareness about its expanded access process and the procedures for obtaining access to investigational drugs, biologics, and medical devices.

Learn more about expanded access categories for drugs and biologics.
Learn more about expanded access categories for medical devices.

What are the roles and responsibilities?

**Patient**
	Consults with licensed physician to explore and decide about alternative options.
	**Licensed Physician**
	Agrees to oversee the patient's treatment and works with industry (e.g., medical product developer), files paperwork with FDA and IRB (for many expanded access request types), and is responsible for patient care and reporting.
	**Company (Industry)**
	Willing to provide the investigational medical product and either sponsors the expanded access, allows the FDA to cross-reference to their industry IND (for drugs and biologics) or IDE (medical devices) on behalf of the expanded access sponsor-investigator through the use of a letter of authorization, or provides the necessary investigational medical product information for the sponsor-investigator to submit to support an expanded access request.
	**Institutional Review Board (IRB)**
	Reviews expanded access protocol and consent to ensure that the patient is informed about the nature of the treatment.
	**FDA**
	Reviews the expanded access request and determines if the treatment may proceed.


What are the different types of expanded access?

Expanded access for individual patients, including for emergency use
	Expanded access for intermediate-size patient groups
	Expanded access for widespread treatment use*Learn more about expanded access categories for investigational drugs and biologics.*

*Learn more about expanded access categories for investigational medical devices.*

**Additional Information on emergency use expanded access:**

FDA may authorize expanded access to an investigational drug or biologic for an individual patient by phone before you submit the written request, or may not object to such investigational use for devices without prior notification, if there is an emergency that requires the patient to be treated.
	For drugs and biologics, emergency requests can be submitted over the phone or other forms of rapid communication (e.g., e-mail) by a licensed physician after receiving agreement from industry to provide the investigational medical product for expanded access use.
	If you have determined that an emergency exists, please follow the instructions on FDA's Expanded Access Contact Information.


What is the licensed physician’s role in the expanded access process?

For an overview of the entire expanded access process, and to familiarize yourself with information available to patients, visit the Patient’s page.

**Licensed Physician Role When a Patient is Seeking Expanded Access to Investigational Medical Products:**

**Determine there are no available clinical trials for the patient.** Wherever possible, an investigational medical product should be used as part of a clinical trial. Information on clinical trials can be found using FDA’s clinical trials search tool or visiting www.clinicalTrials.gov. When enrollment is not possible (e.g., patient ineligibility, lack of ongoing clinical trials) or enrollment in a clinical trial is not feasible (e.g., distance to a trial precludes access), expanded access may be an option for gaining access to an investigational medical product.
	**Confirm patient’s current disease or condition qualifies for expanded access.** You must determine that your patient has either aserious or immediately life-threatening disease or condition and there is no available comparable or satisfactory alternative available for the patient.
	**Identify the appropriate expanded access request type.** There are different types of expanded access requests for investigational drugs and biologics and medical devices. For questions, contact the appropriate FDA organization.
	**Confirm industry will provide investigational medical product.** If your patient meets the criteria for expanded access, you must speak with industry to see if they will provide the investigational medical product for expanded access use. Some resources for discovering availability of expanded access to investigational medical products may include:
	Industry Policy. Contact industry and find out if they are willing to provide the specific investigational medical product being sought for treatment purposes under expanded access.
		Available Programs. Search for specific expanded access programs through an online search engine or the Reagan-Udall Foundation’s Expanded Access Navigator.
		Patient Advocacy Organizations. Contact patient advocacy organizations to see if they have information on expanded access programs for your patient’s disease or condition.
	**Facilitate the process.** After you get the agreement from industry to provide the investigational medical product for use outside of a clinical trial, you will be responsible for managing the use of the investigational medical product and the patient's medical care. This includes:
	Reviewing the requirements for expanded access.
		Evaluating potential risks and potential benefits with the patient.
		Obtaining informed consent, consistent with Federal requirements under 21 CFR 50.
		If you will be the sponsor:
		Submitting an expanded access request to FDA, after reviewing the detailed step-by-step instructions for how to submit an expanded access request
			Submitting follow-up reports to FDA.
		Submitting the expanded access protocol to an institutional review board (IRB) that complies with the Federal IRB requirements under 21 CFR 56. The IRB will be responsible for initial and continuing review and approval of the protocol [Database for Registered IRBs].
	**Manage the treatment.** Treatment can begin after completing the regulatory and institutional requirements for investigational medical product use.*Learn more about expanded access categories for drugs and biologics.*

*Learn more about expanded access categories for medical devices.*


What are the reporting requirements for Sponsor-Investigators of expanded access?

Reporting requirements vary depending on the type of investigational medical product and expanded access request.

Drugs and Biologics:

As with any IND, in all cases of expanded access, sponsors are responsible for submitting IND safety reports (as required by 21 CFR 312.32), and annual reports (as required by 21 CFR 312.33) when the IND or protocol continues for 1 year or longer, to FDA (see 21 CFR 312.305(c)).
	For individual patient expanded access, the regulations (21 CFR 312.310(c)(2)) specify that after treatment the sponsor must provide to FDA a written summary of the results of the expanded access use, including adverse effects.
	See FDA guidance: FDA Guidance: Expanded Access to Investigational Drugs for Treatment Use — Questions & Answers.Medical devices:

For device expanded access requests, sponsors must submit follow-up reports concerning the outcomes of the expanded access use, including any adverse device effects. For individual patient emergency situations, reports should be submitted within 5 days as specified in 21 CFR 812.150(a)(4). Additionally, treatment use IDEs should follow the reporting requirements outlined in 21 CFR 812.36. Visit the medical device expanded access page to learn more about the reporting requirements for each type of device expanded access request.


How do Sponsor-Investigators submit expanded access requests and reports to FDA?

**Drugs or Biologics: Visit the How to Submit a Request (Forms) page for step-by-step instructions.**

**Medical Devices: Visit the medical devices expanded access page.**

*If you are not familiar with the process for submitting a request for expanded access, you may want to contact the appropriate FDA organization or review division before submitting an expanded access request.*


Additional resources

21 CFR 312 Subpart I
Learn more about FDA’s current expanded access regulations for investigational drugs (including biologics).

21 CFR 812.35 - 21 CFR 812.36
Learn more about FDA’s regulations supporting investigational device expanded access.

Clinical Trial Information

Search for possible clinical trials you may qualify for by using our clinical trials search tool or visiting www.clinicalTrials.gov.Expanded Access Search Tools

Reagan-Udall Foundation’s Expanded Access NavigatorForm and Letter Resources

How to submit an expanded access request (form) provides step-by-step instructions for expanded access submissions for investigational drugs and biologics
	Form FDA 3926 and instructions for requests for individual patient expanded access to investigational drugs and biologics, including those for emergency use. It can also be used for certain submissions to FDA after the initial request is filed. (You may need to open this form in a different browser (Internet Explorer) or save the form to your desktop.)
	Quick guide on how to complete Form FDA 1571 and 1572.
	Forms FDA 1571 and 1572 are required for other expanded access submissions (e.g., intermediate access or treatment INDs) and for IND submissions by industry.
	Database for Registered IRBs
	Example template for Informed Consent for Individual Patient IND
	Example wording for Letter of Authorization (LOA)
	Expanded Access eRequest allows physicians to electronically request use of medical products for patients.Guidance Documents

FDA Guidance: Expanded Access to Investigational Drugs for Treatment Use — Questions & Answers
	FDA Final Guidance: Individual Patient Expanded Access Applications: Form FDA 3926
	FDA Guidance: Charging for Investigational Drugs Under an IND — Questions & Answers
	FDA Final Guidance: Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products
	FDA Final Guidance: Informed Consent: Guidance for IRBs, Clinical Investigators, and SponsorsFDA Expanded Access Program Data

Drug, Biologic, and Medical Device expanded access (“compassionate use”) program dataLearning Resources

Expanded Access: Recourse for Patients Out of Options
	Expanded Access: Patient Fact Sheet
	Expanded Access: Physician Fact Sheet
	Expanded Access Video Series for Physicians: In this series of “FDA Drug Info Rounds” videos, the Agency provides an introduction to expanded access, instructions on submitting a single patient investigational new drug application, and tutorials on completing Form FDA 3926 for initial and follow-up submissions.
	FDA Drug Topics: Overview of Expanded Access (EA) Program and EA eRequest Site (Home Study CE Webinar – drug and biologic focus). This webinar discusses and summarizes FDA's expanded access program, including the three types of expanded access and requirements for requesting expanded access. This webinar also provides an overview of FDA’s expanded access program and introduces participants to resources like the EA eRequest site hosted by the *Reagan-Udall Foundation for the FDA*. The EA eRequest site enables physicians to prepare and sign EA requests and submit those requests securely to FDA.
	Information on Personal Importation of MedicineArticles and Reports

Jarow, J. P., Lemery, S., Bugin, K., Khozin, S., & Moscicki, R. (2016). 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. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5135086/
	Jarow, J. P., Lemery, S., Bugin, K., & Lowy, N. (2017). Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety. Therapeutic Innovation & Regulatory Science, 51(2), 246–249. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443559/
	Jarow, J. P. & Moscicki, R. (2017). Impact of Expanded Access on FDA Regulatory Action and Product Labeling. Therapeutic Innovation & Regulatory Science, 51(6), 787-789. Retrieved from: https://journals.sagepub.com/doi/pdf/10.1177/2168479017707800/
	Report from the 2018 external assessment of the Expanded Access Program

                                                                                  Content current as of:
      11/29/2023
              
              
Regulated Product(s)
		 DrugsExpanded Access

          
                        Information for Patients
          Information for Physicians
          Information for Industry
          How to Submit a Request (Forms)
          Keywords, Definitions, and Resources
          Submission Data
          Contact Information
 
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