CDER Fact Sheet Patient Caregiver and Parent

Center for Drug Evaluation and Research (CDER)
Emergency Use Authorization (EUA) Template:
Fact Sheet for Patients and Caregivers/Parents for
Unapproved Products and the Unapproved Use of Approved Products
Instructions:
The following template provides recommendations for information to include when
developing an Emergency Use Authorization (EUA) Fact Sheet for Patients and
Parents/Caregivers for a CDER-regulated product. This template is intended to help
facilitate the preparation, submission, and authorization of the Patients and
Caregivers/Parents Fact Sheet as part of an EUA, but is not required. Developers who
intend to use alternative approaches should consider seeking CDER's feedback or
recommendations.
Template Key:
 TEXT – Indicates a field that the user will replace.
 TEXT – Indicates instructions containing choices or options that will be deleted.
 TEXT – Indicates instructions that will be deleted and do NOT contain choices or
options

FACT SHEET TEMPLATE BEGINS ON NEXT PAGE

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Fact Sheet for Patients, PARENTS, AND CAREGIVERS
Emergency Use Authorization (EUA) of DRUG-X for
EMERGENCY CONDITION/DISEASE STATE-X
You are being given this fact sheet because your healthcare provider believes it is necessary to
provide you with DRUG-X for AUTHORIZED USE. PROVIDE A SHORT SUMMARY OF THE
AUTHORIZED USE IN PATIENT FRIENDLY LANGUAGE, WHILE ENSURING
CONSISTENCY WITH THE AUTHORIZED USE IN THE LETTER OF AUTHORIZATION
[LOA]. This fact sheet contains information to help you understand the risks and benefits of
taking DRUG-X.
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization
(EUA) to make DRUG-X available during the DESCRIBE EMERGENCY (for more details
about an EUA please see “What is an Emergency Use Authorization?” at the end of this
document). DRUG-X is not AN FDA-APPROVED MEDICINE, OR, ALTERNATIVELY, FOR
APPROVED DRUGS THAT HAVE ADDITIONAL AUTHORIZED USES UNDER EUAS,
STATE: “NOT FDA-APPROVED FOR THIS USE” in the United States. Read this Fact
Sheet for information about DRUG-X. Talk to your healthcare provider about your options or
if you have any questions. It is your choice to take DRUG-X.
What is EMERGENCY CONDITION/DISEASE STATE?
INCLUDE A BRIEF DESCRIPTION OF THE CONDITION/DISEASE STATE AND COMMON
SYMPTOMS. NO INFORMATION THAT IS OUTSIDE THE SCOPE OF THE DRUG’S
AUTHORIZATION (E.G., AGE, SEVERITY OF DISEASE, SPECIFIC ENDPOINTS, ETC.)
SHOULD BE INCLUDED BECAUSE OF THE PROMOTIONAL IMPLICATIONS FOR
CONSUMER/PATIENT DIRECTED PROMOTIONAL MATERIALS.
What is DRUG-X?
INCLUDE A BRIEF DESCRIPTION OF THE DRUG AND ITS KNOWN OR POTENTIAL
BENEFITS, AS DESCRIBED IN THE LOA.
The FDA has authorized the emergency use of DRUG-X for AUTHORIZED USE under an
EUA. For more information on EUA, see the “What is an Emergency Use Authorization
(EUA)?” section at the end of this Fact Sheet.
What should I tell my healthcare provider before I take DRUG-X?
Tell your healthcare provider if you:
 Have any allergies
 Have kidney or liver disease OPTIONAL, DEPENDING ON THE DRUG
 Are pregnant or plan to become pregnant
 Are breastfeeding or plan to breastfeed
 Have any serious illnesses
 Are taking any other medicines including prescription and over-the-counter, vitamins,
or herbal products
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

In particular, notify your healthcare provider if you are taking NAME PRODUCTS
THAT INTERACT WITH THE DRUG.

How do I take DRUG-X? / How will I receive DRUG-X?
INCLUDE ANY SPECIAL DOSING OR DETAILED ADMINISTRATION INSTRUCTIONS (e.g.,
ADULT VERSUS PEDIATRIC PATIENTS), IF APPROPRIATE.
Who should not take DRUG-X?
Do not take DRUG-X if:
INCLUDE THIS QUESTION AND RESPONSE IF THERE ARE CONTRAINDICATIONS FOR
USE OF THE PRODUCT FOR THE AUTHORIZED USE.
What are the important possible side effects of DRUG-X?
INCLUDE IMPORTANT POSSIBLE SIDE EFFECTS, INCLUDING ANY BOX WARNINGS.
What other treatment choices are there?
INCLUDE LANGUAGE ASSURING PATIENTS WHO CHOOSE NOT TO RECEIVE DRUG-X
THAT THEY SHOULD CONTINUE TO RECEIVE THE STANDARD OF CARE AS FOLLOWS:
It is your choice for YOU OR YOUR CHILD to be treated or not to be treated with DRUG-X.
Should you decide not to receive it OR FOR YOUR CHILD TO NOT RECEIVE IT, it will not
change your OR YOUR CHILD’S standard medical care.
What should I avoid while taking DRUG-X?
INCLUDE ANYTHING THAT SHOULD BE AVOIDED WHILE TAKING DRUG-X, SUCH AS
“DON’T OPERATE HEAVY MACHINERY,” OR “DON’T DRIVE.”
What if I am pregnant or breastfeeding?
How do I report side effects with DRUG-X?
Contact your healthcare provider if you have any side effects that bother you or do not go
away. Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA1088. IF APPLICABLE, INCLUDE STATEMENT “YOU MAY ALSO REPORT SIDE EFFECTS
TO [SPONSOR NAME] BY CALLING [SPONSOR PHONE NUMBER].”
How should I store DRUG-X?
INCLUDE THIS QUESTION AND A RESPONSE IF THE PATIENT OR PARENT/CAREGIVER
WILL NEED TO STORE THE DRUG.
How can I learn more about EMERGENCY CONDITION/DISEASE STATE?
 Ask your healthcare provider
 Visit CDC WEBSITE, IF AVAILABLE
 Contact your local or state public health department
What is an Emergency Use Authorization?

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The United States FDA has made DRUG-X available under an emergency access
mechanism called an Emergency Use Authorization (EUA). The EUA is supported by a
Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify
the emergency use of drugs and biological products during the DESCRIBE EMERGENCY.
DRUG-X for AUTHORIZED USE has not undergone the same type of review as an FDAapproved product. In issuing an EUA under the DESCRIBE EMERGENCY, the FDA has
determined, among other things, that based on the total amount of scientific evidence
available, including data from adequate and well-controlled clinical trials, if available, it is
reasonable to believe that the product may be effective for diagnosing, treating, or preventing
EMERGENCY CONDITION/DISEASE STATE, or a serious or life-threatening disease or
condition caused by chemical, biological, radiological, or nuclear (CBRN); that the known
and potential benefits of the product, when used to diagnose, treat, or prevent such disease
or condition, outweigh the known and potential risks of such product; and that there are no
adequate, approved and available alternatives.
All of these criteria must be met to allow for the product to be used in the treatment of
patients during the DESCRIBE EMERGENCY. The EUA for DRUG-X is in effect for the
duration of the DESCRIBE EMERGENCY declaration justifying emergency use of DRUG-X,
unless terminated or revoked (after which DRUG-X may no longer be used under the EUA).
Manufacturer Information:
FOR DRUG AND BIOLOGICAL PRODUCTS INCLUDE:
 MANUFACTURER NAME (E.G., “MANUFACTURED BY”) (AND IF APPLICABLE
ALSO INCLUDE PACKER AND DISTRIBUTOR, E.G., “PACKAGED BY”,
“DISTRIBUTED BY”)
 LOCATION OF BUSINESS (STREET ADDRESS, CITY, STATE, AND ZIP CODE)

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