Individual Patient Expanded 
Access Applications:  
Form FDA 3926 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
 
 
 
June 2016 
Updated October 2017 
Procedural 
 
 
 
OMB control number 0910-0814 
Current expiration date available at https://www.reginfo.gov 
(Search ICR and enter OMB control number 0910-0814) 
See additional PRA statement in section V of this guidance. 
 
   
Individual Patient Expanded 
Access Applications:  
Form FDA 3926 
 
Guidance for Industry 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
and/or 
 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm    
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
  
 
June 2016 
Updated October 2017 
Procedural 
   
   
Individual Patient Expanded 
Access Applications:  
Form FDA 3926 
 
Guidance for Industry 
 
 
 
 
NOTE: FDA updated Section III of this guidance in October 2017 to clarify the IRB review 
requirements for individual patient expanded access treatment use of investigational 
drugs.   The changes to Form 3926 are intended to allow for a waiver of the requirement 
for review and approval at a convened IRB meeting if the physician obtains concurrence 
by the IRB chairperson (or designated IRB member) before the treatment use begins.  
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
 
 
 
June 2016 
Updated October 2017 
Procedural 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
A.  Expanded Access for an Individual Patient ................................................................................. 3 
B.  Emergency Expanded Access for an Individual Patient ............................................................ 5 
III.  CONSIDERATIONS AND REGULATORY REQUIREMENTS IN REQUESTING 
EXPANDED ACCESS FOR AN INDIVIDUAL PATIENT ......................................... 5 
IV.  PROCEDURES AND TIMELINE FOR PROCESSING FORM FDA 3926 .............. 6 
V.  PAPERWORK REDUCTION ACT OF 1995 ................................................................ 7 
i  Contains Nonbinding Recommendations 
 
Individual Patient Expanded Access Applications:  
Form FDA 3926 
Guidance for Industry1 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page.   
 
 
 
 
I.  INTRODUCTION  
 
This guidance describes Form FDA 39262 (Individual Patient Expanded Access  
Investigational New Drug Application (IND)), which is available for licensed physicians to use 
for expanded access requests for individual patient INDs.  The terms compassionate use and 
preapproval access are also occasionally used in the context of the use of an investigational 
drug to treat a patient; however, these terms are not defined or described in FDA regulations.  
Individual patient expanded access allows for the use of an investigational new drug3 outside 
of a clinical investigation, or the use of an approved drug where availability is limited by a risk 
evaluation and mitigation strategy (REMS), for an individual patient who has a serious or 
immediately life- threatening disease or condition and there is no comparable or satisfactory 
alternative therapy to diagnose, monitor, or treat the disease or condition.  Form FDA 3926 
provides a streamlined alternative for submitting an IND under 21 CFR 312.23 for use in cases 
of individual patient expanded access, including for emergency use.  This guidance and Form 
FDA 3926 do not apply to other types of expanded access requests, including requests for 
expanded access for medical devices. 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
 
1 This guidance has been prepared by the Office of the Commissioner, Office of Policy, Planning, Legislation, and 
Analysis, in cooperation with the Center for Drug Evaluation and Research and the Center for Biologics Evaluation 
and Research at the Food and Drug Administration. 
  
2 FDA forms are available on the internet at 
https://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm. 
 
3 For the purposes of this guidance, the terms investigational new drug, investigational drug, drug, and drug product 
refer to both human drugs and biological products regulated by the Center for Drug Evaluation and Research or the 
Center for Biologics Evaluation and Research. 
  1  Contains Nonbinding Recommendations 
 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  
 
 
II.  BACKGROUND 
 
Expanded access refers to the use of an investigational drug when the primary purpose is to 
diagnose, monitor, or treat a patient rather than to obtain the kind of information about the drug 
that is generally derived from clinical trials.  FDA has a long history of facilitating access to 
investigational drugs for treatment use for patients with serious or immediately life-threatening 
diseases or conditions4 who lack therapeutic alternatives.  FDA revised its IND regulations in 
20095 by removing the existing regulations on treatment use and creating subpart I of 21 CFR 
part 312 to consolidate and expand the various provisions regarding expanded access to 
treatment use of investigational drugs. 
 
Subpart I describes the three categories of expanded access: 
 
  Expanded access for individual patients, including for emergency use (21 CFR 312.310) 
 
  Expanded access for intermediate-size patient populations (generally smaller than those 
typical of a treatment IND or treatment protocol  a treatment protocol is submitted as a 
protocol to an existing IND by the sponsor of the existing IND)6  (21 CFR 312.315) 
 
  Expanded access for widespread treatment use through a treatment IND or treatment 
protocol (designed for use in larger patient populations) (21 CFR 312.320) 
 
The revised regulations were, among other things, intended to increase awareness and knowledge 
about expanded access and the procedures for obtaining investigational drugs for treatment use 
for patients with serious or immediately life-threatening diseases or conditions who lack 
therapeutic alternatives.  The regulations were also intended to facilitate the availability, when 
appropriate, of investigational new drugs for treatment use while protecting patient safety and 
 
4 For the purpose of expanded access to investigational drugs for treatment use, immediately life-threatening disease 
or condition means a stage of disease in which there is reasonable likelihood that death will occur within a matter of 
months or in which premature death is likely without early treatment.  Serious disease or condition means a disease 
or condition associated with morbidity that has substantial impact on day-to-day functioning.  Short-lived and self- 
limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible, provided it is persistent 
or recurrent.  Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such 
factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a 
less severe condition to a more serious one (21 CFR 312.300(b)). 
 
5 Federal Register of August 13, 2009 (74 FR 40900).  
 
6 For information on the types of regulatory submissions that can be used to obtain expanded access, including 
treatment INDs or treatment protocols, see the guidance for industry Expanded Access to Investigational Drugs for 
Treatment Use  Questions and Answers.  We update guidances periodically.  To make sure you have the most 
recent version of a guidance, check the FDA guidance web page at 
https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. 
  2  Contains Nonbinding Recommendations 
 
avoiding interference with the development of investigational drugs for marketing under 
approved applications. 
 
The regulations describe criteria that must be met to authorize expanded access use, requirements 
for expanded access submissions, and safeguards that are intended to protect patients and 
preserve the ability to develop meaningful data about the safety and effectiveness of the drug 
through clinical trials or drug development. 
 
A.  Expanded Access for an Individual Patient 
 
FDA may permit expanded access to an investigational new drug outside of a clinical 
investigation, or to an approved drug where availability is limited by a REMS, for an 
individual patient when the applicable criteria in  312.305(a) (which apply to all types of 
expanded access) and  312.310(a) (which apply specifically to individual patient expanded 
access, including for emergency use) are met. 
 
Under the applicable criteria in  312.305(a), FDA must determine that: 
 
  The patient to be treated has a serious or immediately life-threatening disease or 
condition, and there is no comparable or satisfactory alternative therapy to diagnose, 
monitor, or treat the disease or condition; 
 
  The potential patient benefit justifies the potential risks of the treatment use and those 
potential risks are not unreasonable in the context of the disease or condition to be 
treated; and 
 
  Providing the investigational drug for the requested use will not interfere with the 
initiation, conduct, or completion of clinical investigations that could support marketing 
approval of the expanded access use or otherwise compromise the potential development 
of the expanded access use. 
 
Under the applicable criteria in  312.310(a): 
 
  The patients physician must determine that the probable risk to the person from the 
investigational drug is not greater than the probable risk from the disease or condition; 
and 
 
  FDA must determine that the patient cannot obtain the investigational drug under another 
IND or protocol. 
 
For further information regarding those determinations, please see the guidance for industry 
Expanded Access to Investigational Drugs for Treatment Use  Questions & Answers.7    In 
 
7 For information on expanded access in general, including submitting an expanded access protocol to an existing 
IND, see the guidance for industry Expanded Access to Investigational Drugs for Treatment Use  Questions and 
Answers.  In a separate guidance, Charging for Investigational Drugs under an IND  Questions and Answers, 
FDA provides answers to questions concerning the regulations on charging for investigational drugs under an IND 
  3  Contains Nonbinding Recommendations 
 
addition,  312.305(b) of FDAs expanded access regulations sets forth the submission 
requirements for all types of expanded access requests.  Section 312.310(b) contains additional 
submission requirements for individual patient expanded access requests.  A physician 
submitting a request for individual patient expanded access may satisfy some of the submission 
requirements by referring to information in an existing IND, ordinarily one held by the 
investigational drugs manufacturer, if the physician obtains permission from that IND holder 
(e.g., the drug manufacturer or pharmaceutical company) ( 312.305(b)(1)).  If permission is 
obtained, the physician should then provide to FDA a letter of authorization (LOA) from the 
existing IND holder that permits FDA to reference that IND. 
 
One of the requirements under  312.305(b)(2) is that a cover sheet must be included meeting 
the requirements of  312.23(a). This provision applies to several types of submissions under 
part 312, ranging from commercial INDs under  312.23 that involve large groups of patients 
enrolled in clinical trials to requests from physicians to use an investigational drug for an 
individual patient.  Form FDA 1571 (Investigational New Drug Application (IND)) is currently 
used by sponsors for all types of IND submissions.  However, FDA is concerned that physicians 
requesting expanded access for an individual patient may have encountered difficulty in 
completing Form FDA 1571 and providing the associated documents because Form FDA 1571 is 
not tailored to requests for individual patient expanded access. 
 
To streamline the submission process for individual patient expanded access INDs, FDA 
developed Form FDA 3926, which is available for physicians to use to request expanded access 
to an investigational drug outside of a clinical investigation, or to an approved drug where 
availability is limited by a REMS, for an individual patient who has a serious or immediately 
life-threatening disease or condition and there is no comparable or satisfactory alternative 
therapy to diagnose, monitor, or treat the disease or condition.  FDA generally intends to accept 
submission of a completed Form FDA 3926 to comply with the IND submission requirements in 
 312.23, 312.305(b), and 312.310(b).  FDA intends to consider a completed Form FDA 3926 
with the box in Field 10.a. checked and the form signed by the physician to be a request in 
accordance with  312.10 for a waiver of any additional requirements in part 312 for an IND 
submission, including additional information ordinarily provided in Form FDA 1571 and Form 
FDA 1572 (Statement of Investigator, which provides the identity and qualifications of the 
investigator conducting the clinical investigation).  FDA concludes that such a waiver of any 
additional requirements is appropriate for requests for individual patient expanded access INDs 
because the physicians noncompliance with any such requirements would not pose a significant 
and unreasonable risk to the individual patient, and the physicians compliance with any such 
requirements is unnecessary for the Agency to evaluate the IND. 
 
Form FDA 3926 may also be used for certain follow-up submissions to an individual patient 
expanded access IND, which include the following:  Initial Written IND Safety Report 
( 312.32(c)); Follow-up to a Written IND Safety Report ( 312.32(d)); Annual Report 
( 312.33); Summary of Expanded Access Use (treatment completed) ( 312.310(c)(2)); Change 
in Treatment Plan ( 312.30); General Correspondence or Response to FDA Request for 
Information ( 312.41); and Response to Clinical Hold ( 312.42(e)). 
 
(21 CFR 312.8).  For additional information on expanded access, also see FDAs website at 
https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm.  
  4  Contains Nonbinding Recommendations 
 
 
B.  Emergency Expanded Access for an Individual Patient 
 
Under  312.310(d), in an emergency situation that requires the patient to be treated before a 
written submission can be made, the request to use the investigational drug for individual patient 
expanded access may be made by telephone (or other rapid means of communication) to the 
appropriate FDA review division.  Authorization of the emergency use may be given by an FDA 
official by telephone, provided the physician explains how the expanded access use will meet the 
requirements of  312.305 and 312.310 and agrees to submit an expanded access application 
within 15 working days of FDAs initial authorization of the expanded access use 
( 312.310(d)(2)).  The physician may choose to use Form FDA 3926 for the expanded access 
application. 
 
 
III.  CONSIDERATIONS AND REGULATORY REQUIREMENTS IN REQUESTING 
EXPANDED ACCESS FOR AN INDIVIDUAL PATIENT 
 
When a licensed physician would like to obtain an investigational drug outside of a clinical 
investigation, or an approved drug where availability is limited by a REMS, for an individual 
patient, the physician should first ensure that the investigational drug can be obtained.  If so, 
the physician should obtain an LOA from the entity that is the sponsor of the IND (e.g., 
commercial sponsor or drug manufacturer) being referenced.  The LOA permits FDA to refer 
to information that the sponsor of the IND has submitted to FDA (e.g., in a commercial IND).  
In cases where it is not possible to obtain an LOA (e.g., the entity supplying the drug does not 
have an IND filed with FDA), the physician should contact the relevant review division at 
FDA to determine what information is needed to support the expanded access submission.  
Physicians should also contact the review division if the individual patient expanded access 
IND is for an approved drug where availability is limited by a REMS.  The physician should 
then submit an individual patient expanded access IND to the appropriate FDA review division 
and may choose to use Form FDA 3926.  Contact information for review divisions may be 
found on FDAs website at 
https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/uc
m429610.htm. 
 
Under individual patient expanded access INDs, the physician who submits an IND is 
considered a sponsor-investigator (as defined in  312.3) and is responsible for complying with 
the responsibilities for both sponsors and investigators to the extent they are applicable to the 
expanded access use, including submitting IND safety reports8 and annual reports and 
maintaining adequate drug disposition records.  The responsibilities of sponsors and 
investigators are described in subpart D of 21 CFR part 312 and in related guidance documents, 
for example, in the guidance for industry Investigator ResponsibilitiesProtecting the Rights, 
Safety, and Welfare of Study Subjects. 
 
 
8 For additional information about FDAs IND safety reporting requirements, please see the guidance for industry 
and investigators Safety Reporting Requirements for INDs and BA/BE Studies. 
 
  5  Contains Nonbinding Recommendations 
 
The informed consent requirements in 21 CFR part 50 apply to treatment provided to patients 
under expanded access INDs, and informed consent must be obtained before initiating 
treatment, including in the case of emergency use, unless one of the exceptions found in part 
50 applies.9 Additionally, the institutional review board (IRB) requirements found in 21 CFR 
part 56 apply (see  312.305(c)(4)), and IRB approval must be obtained before starting 
treatment under an expanded access IND unless it is for emergency use (in which case the IRB 
must be notified of the emergency expanded access use within 5 working days of treatment 
( 56.104(c)).10 Upon request, FDA intends to allow for waivers of the requirement for review 
and approval at a convened IRB meeting for individual patient expanded access INDs where 
the IRB chairperson or another designated IRB member provides concurrence, as described in 
the next paragraph. 
 
For individual patient expanded access use of an investigational drug, FDA intends to consider 
a completed Form FDA 3926 with the box in Field 10.b. checked and the form signed by the 
physician to be a request for a waiver under  56.105 of the requirements in  56.108(c), 
which relate to IRB review and approval at a convened IRB meeting at which a majority of the 
members are present.11  FDA concludes that such a waiver is appropriate for individual patient 
expanded access INDs when the physician obtains concurrence by the IRB chairperson or 
another designated IRB member before treatment use begins. 
 
Form FDA 3926 and accompanying instructions may be found on FDAs website at 
https://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm. 
 
 
IV.  PROCEDURES AND TIMELINE FOR PROCESSING FORM FDA 3926 
 
In a non-emergency situation, after receiving Form FDA 3926 (i.e., the IND), FDA will assign 
an individual IND number to the IND and will either allow the treatment use to proceed or put 
the application on clinical hold (see  312.42).  The IND will go into effect (i.e., treatment 
 
9 For information on informed consent in general, see the draft guidance for IRBs, clinical investigators, and 
sponsors Informed Consent Information Sheet.  When final, this guidance will represent FDAs current thinking 
on this topic.  For additional information on the part 50 informed consent exceptions, see the guidance for 
institutional review boards, clinical investigators, and sponsors Exception from Informed Consent Requirements 
for Emergency Research. 
 
10 An IRB means any board, committee, or other group formally designated by an institution to review, to 
approve the initiation of, and to conduct periodic review of biomedical research involving human subjects.  The 
primary purpose of IRB review is to assure that the rights and welfare of human subjects are protected, including 
by determining that informed consent is obtained in accordance with and to the extent required by Federal 
requirements.  Institutions may have their own IRB to oversee human subjects research conducted within the 
institution or by the staff of the institution.  If the physician does not have access to a local IRB, an independent 
IRB may be used.  The Department of Health & Human Services Office for Human Research Protections 
maintains a database of registered IRBs.  Go to  https://ohrp.cit.nih.gov/search/irbsearch.aspx?styp=bsc and click 
on Advanced Search. Enter your state to find registered IRBs in your area. 
 
11 Form FDA 1571 does not provide a field for requesting a waiver under  56.105.  However, a physician 
submitting an individual patient expanded access IND using Form FDA 1571 may include a separate waiver 
request with the application. 
  6  Contains Nonbinding Recommendations 
 
with the investigational drug may proceed) after FDA notifies the physician or, if no 
notification occurs, 30 days after FDA receives the completed Form FDA 3926.  FDA 
generally provides the sponsor with notification acknowledging the complete submission.  If 
the treatment use is not allowed to proceed, FDA generally will notify the physician of this 
decision initially by telephone (or other rapid means of communication) and will follow up 
with a written letter that details the reasons for FDAs decision to place the IND on clinical 
hold. 
 
If there is an emergency and authorization of the expanded access use is requested before a 
written submission can be made, the physician must explain how the expanded access use will 
meet the criteria of  312.305(a) and 312.310(a), as described previously in section II.  In 
these situations, FDA may authorize the expanded access use of the investigational drug, and 
treatment may begin before FDAs receipt of the written submission (including the LOA), but 
the physician must agree to submit an expanded access submission within 15 working days of 
FDAs authorization of the expanded access use ( 312.310(d)).  When treatment involves the 
emergency use of an investigational drug and approval from an IRB cannot be obtained before 
treatment, treatment may begin without prior IRB approval provided the IRB is notified of the 
emergency expanded access use within 5 working days of treatment ( 56.104). 
 
Secure email between FDA and sponsors is useful for informal communications when 
confidential information may be included in the message (e.g., confidential patient information).  
Parties who would like to establish secure email with FDA should email a request to 
SecureEmail@fda.hhs.gov. 
 
 
V.  PAPERWORK REDUCTION ACT OF 1995 
 
This guidance contains information collection provisions that are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520).  The time required to complete this information collection is estimated 
to average 45 minutes per response, including the time to review instructions, search existing 
data sources, gather the data needed, and complete and review the information collection.  
Send comments regarding this burden estimate or suggestions for reducing this burden to: 
 
Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Avenue, Bldg. 51, rm. 6337, Silver Spring, 
MD 20993-0002 
 
This guidance also refers to previously approved collections of information found in FDA 
regulations.  The collections of information in 21 CFR part 312 have been approved under 
OMB control number 0910-0014.
 
 
An Agency may not conduct or sponsor, and a person is not required to respond to, a collection 
of information unless it displays a currently valid OMB control number.  The OMB control 
number for this information collection is 0910-0814.  The current expiration date is available at 
https://www.reginfo.gov (search ICR and enter OMB control number 0910-0814). 
  7