CDER Fact Sheet Healthcare Provider

Center for Drug Evaluation and Research (CDER)
Emergency Use Authorization (EUA) Template:
Fact Sheet for Healthcare Providers 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 Healthcare Providers for a CDER-regulated
product. This template is intended to help facilitate the preparation, submission, and authorization of
the Healthcare Provider 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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OMB Control Number: 0910-XXXX; Expiration Date: TBD

FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE
AUTHORIZATION FOR DRUG-X
HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA)
These highlights of the EUA do not include all the information
needed to use DRUG-X under the EUA. See the FULL FACT
SHEET FOR HEALTHCARE PROVIDERS for DRUG-X.
DRUG-X dosage form, route of administration
Original EUA Authorized Date: MM/YYYY
Fact Sheet Revised Date: MM/YYYY
WARNING: TITLE OF WARNING
See Full Fact Sheet for Healthcare Providers for the complete
boxed warning.
INCLUDE A BOXED WARNING FOR CONTRAINDICATIONS OR
SERIOUS ADVERSE REACTIONS OR RISKS, PARTICULARLY
THOSE THAT MAY LEAD TO DEATH OR SERIOUS INJURY.
----------------------------RECENT MAJOR CHANGES-------------------------Section Title, Subsection Title (XX)
M/YYYY
Section Title, Subsection Title (Xuxa)
M/YYYY
----------------------------------EUA FOR DRUG-X-------------------------------The U.S. Food and Drug Administration has issued an EUA for the
emergency use of DRUG-X for INCLUDE EUA AUTHORIZED USE.
However, DRUG-X is not approved for this use.
See Full Fact Sheet for Healthcare Providers for the justification for
emergency use of drugs during the EMERGENCY, limitations of
authorized use, information on available alternatives, and additional
information on EMERGENCY.
------------------------DOSAGE AND ADMINISTRATION----------------------PROVIDE A SUMMARY OF THE ESSENTIAL DOSAGE,
PREPARATION, AND ADMINISTRATION INSTRUCTIONS FOR THE
AUTHORIZED USE.

---------------------DOSAGE FORMS AND STRENGTHS---------------------Dosage form(s): strength(s) (3)
-------------------------------CONTRAINDICATIONS-----------------------------IF NO CONTRAINDICATIONS HAVE BEEN IDENTIFIED INCLUDE
THE FOLLOWING OR SIMILAR STATEMENT.
No contraindications have been identified based on the limited
available data on the emergency use of DRUG-X authorized under this
EUA. (4)
------------------------WARNINGS AND PRECAUTIONS----------------------• Text (5.x)
• Text (5.x)
-------------------------------ADVERSE REACTIONS-----------------------------Most common adverse reactions (incidence > x%) are TEXT (6.x)
You or your designee must report all SERIOUS ADVERSE
EVENTS or MEDICATION ERRORS potentially related to DRUG-X
(1) by submitting FDA Form 3500 online, (2) by downloading this
form and then submitting by mail or fax, or (3) contacting the FDA
at 1-800-FDA-1088 to request this form. Please also provide a
copy of this form to NAME OF FIRM THAT IS RESPONSIBLE FOR
COLLECTING THESE REPORTS at TOLL-FREE PHONE # FOR
FIRM (6.4).
------------------------------DRUG INTERACTIONS-------------IF DRUG INTERACTIONS HAVE NOT BEEN IDENTIFIED, INCLUDE
THE FOLLOWING OR SIMILAR STATEMENT.
No drug interactions have been identified based on the limited
available data on the emergency use of DRUG-X authorized under this
EUA. (7.x)
--------------------------USE IN SPECIFIC POPULATIONS--• Text (8.x)
• Text (8.x)
See FACT SHEET FOR PATIENTS AND PARENTS/CAREGIVERS.

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TABLE OF CONTENTS*
WARNING: SUBJECT OF WARNING
1 EUA FOR DRUG-X
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
6.1 Adverse Reactions from Clinical Studies
6.2 Adverse Reactions from Spontaneous Reports
6.3 Required Reporting for Serious Adverse Events and
Medication Errors
7 DRUG INTERACTIONS
7.1 SUBSECTION TITLE
7.2 SUBSECTION TITLE
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 SUBPOPULATION X

9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
12.5 Pharmacogenomics
12.6 Immunogenicity
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
18 MANUFACTURER INFORMATION
* Sections or subsections omitted from the EUA are not listed

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OMB Control Number: 0910-XXXX; Expiration

FULL FACT SHEET FOR HEALTHCARE PROVIDERS
WARNING: TITLE OF WARNING
INCLUDE A BOXED WARNING FOR CONTRAINDICATIONS OR SERIOUS ADVERSE
REACTIONS OR RISKS, PARTICULARLY THOSE THAT MAY LEAD TO DEATH OR
SERIOUS INJURY. HIGHLIGHT (1) ADVERSE REACTIONS THAT ARE SO SERIOUS IN
PROPORTION TO THE POTENTIAL BENEFIT FROM THE PRODUCT THAT IT IS ESSENTIAL
THAT IT BE CONSIDERED IS ASSESSING THE RISKS AND BENEFITS OF USING THE
PRODUCT AND (2) SERIOUS ADVERSE REACTIONS THAT CAN BE PREVENTED OR
REDUCED IN FREQUENCY OR SEVERITY BY APPROPRIATE USE OF THE PRODUCT.
PROVIDE A BRIEF, CONCISE SUMMARY OF THIS INFORMATION IN BOLD FONT.
1 EMERGENCY USE AUTHORIZATION FOR DRUG-X
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for
the emergency use of DRUG-X for EUA AUTHORIZED USE. However, DRUG-X is not FDA
approved for this use.
Justification for Emergency Use of Drugs During the EMERGENCY
INCLUDE THE FOLLOWING INFORMATION ABOUT THE JUSTIFICATION FOR EMERGENCY
USE OF DRUGS AND/OR BIOLOGICAL PRODUCTS DURING THE EMERGENCY,
BACKGROUND ON EUAS, AND THE CRITERIA FOR EUAS.
There is currently DESCRIBE EMERGENCY OR THREAT OF EMERGENCY. The Secretary of
Health and Human Services (HHS) has declared that circumstances exist justifying the authorization
of emergency use of DRUGS AND/OR BIOLOGICAL PRODUCTS during the EMERGENCY
(XX/XX/XXXX declaration) based on INSERT APPLICABLE 21 USC 564(b)(1) DETERMINATION
LANGUAGE.
An EUA is an FDA authorization for the emergency use of an unapproved product or unapproved use
of an approved product (i.e., drug, biological product, or device) in the United States under certain
circumstances.
Criteria for issuing an EUA include:
•
•

•

The chemical, biological, radiological, or nuclear agent(s) can cause a serious or life-threatening
disease or condition;
Based on the totality of the available scientific evidence (including data from adequate and wellcontrolled clinical trials, if available), it is reasonable to believe that
• the product may be effective in diagnosing, treating, or preventing the serious or lifethreatening disease or condition; and
• The known and potential benefits of the product - when used to diagnose, prevent, or
treat such disease or condition - outweigh the known and potential risks of the product,
taking into consideration the material threat posed by the biological agent(s);
There is no adequate, approved, and available alternative to the product for diagnosing,
preventing, or treating the serious or life-threatening disease or condition.

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Information Regarding Approved or Authorized Available Alternatives for the EUA Authorized Use
INCLUDE INFORMATION REGARDING APPROVED OR AUTHORIZED AVAILABLE
ALTERNATIVES FOR THE EUA AUTHORIZED USE INCLUDING THE BENEFITS AND RISKS OF
THESE ALTERNATIVES. FOR EXAMPLE, IF THERE ARE OTHER PRODUCTS THAT MAY
TREAT THE AUTHORIZED USE OF DRUG-X, CLARIFY WHY THEY ARE NOT ADEQUATE AND
THE EUA FOR DRUG-X IS NEEDED (e.g., LIMITATIONS OF THE ALTERNATIVE THERAPIES AT
REDUCING THE RISK OR TREATING THE AUTHORIZED USE). FURTHERMORE, INCLUDE
THE FOLLOWING STATEMENT.
For information on clinical studies of DRUG-X and other therapies for the INCLUDE THE
APPROPRIATE TERM: TREATMENT/RISK REDUCTION of CONDITION OR DISEASE, see
www.clinicaltrials.gov.
2 DOSAGE AND ADMINISTRATION
INCLUDE THE RECOMMENDED AUTHORIZED DOSAGE (e.g., RECOMMENDED STARTING
DOSAGE, RECOMMENDED TITRATION SCHEDULE, MAXIMUM RECOMMENDED DOSAGE,
MAXIMUM RECOMMENDED DURATION) AND ADMINISTRATION INSTRUCTIONS (e.g.,
RECOMMENDED INTRAVENOUS INFUSION RATE AND INFUSION DURATION,
RECOMMENDED INJECTION SITES FOR DRUGS ADMINISTERED INTRAMUSCULARLY OR
SUBCUTANEOUSLY. FOR EXAMPLE:
The recommended dosage for emergency use of DRUG-X authorized under this EUA is INSERT
RECOMMENDED DOSAGE AND ADMINISTRATION.
IN ADDITION, INCLUDE IF APPLICABLE:
•
•
•
•
•
•
•
•
•

CRITICAL TESTS, PROCEDURES, AND/OR EVALUATIONS NEEDED PRIOR TO
ADMINISTRATION
REQUIRED AND/OR RECOMMENDED PRE-MEDICATION AND/OR CONCOMITANT
THERAPIES TO ENHANCE SAFETY OR EFFICACY
DOSAGE MODIFICATIONS DUE TO ADVERSE REACTIONS OR DUE TO DRUG
INTERACTIONS
DOSAGE IN SPECIFIC POPULATIONS (e.g., PATIENTS WITH RENAL OR HEPATIC
IMPAIRMENT)
RECOMMENDATIONS FOR DISCONTINUATION
PREPARATION INSTRUCTIONS (e.g., RECONSTITUTION OF A LYOPHILIZED POWDER,
DILUTION)
ADMINISTRATION INSTRUCTIONS
STORAGE CONDITIONS NEEDED TO MAINTAIN THE STABILITY AND STERILITY OF
THE RECONSTITUTED AND/OR DILUTED PRODUCT.
DISPOSAL INSTRUCTIONS

3 DOSAGE FORMS AND STRENGTHS
INCLUDE THE DOSAGE FORM(S), STRENGTH(S), AND THE IDENTIFYING CHARACTERISTICS
OF THE DOSAGE FORM(S).
4 CONTRAINDICATIONS
MUST INCLUDE CONTRAINDICATIONS. CONTRAINDICATIONS ARE DEFINED AS
SITUATIONS IN WHICH DRUG-X MUST NOT BE USED BECAUSE THE RISK OF USE CLEARLY
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OUTWEIGHS ANY POSSIBLE THERAPEUTIC BENEFIT. IF NO CONTRAINDICATIONS HAVE
BEEN IDENTIFIED INCLUDE THE FOLLOWING OR SIMILAR STATEMENT.
No contraindications have been identified based on the limited available data on the emergency use
of DRUG-X authorized under this EUA.
5 WARNINGS AND PRECAUTIONS
DESCRIBE CLINICALLY SIGNIFICANT ADVERSE REACTIONS OR RISKS ASSOCIATED WITH
THE USE OF DRUG-X, THE FREQUENCY/RATE OF OCCURRENCE OF THESE ADVERSE
REACTIONS, LIMITATIONS OF USE IMPOSED BY THEM, AND STEPS TO TAKE TO PREVENT,
MITIGATE, MONITOR FOR, OR MANAGE THESE CLINICALLY SIGNIFICANT ADVERSE
REACTIONS OR RISKS. INCLUDE EACH CLINICALLY SIGNIFICANT REACTION OR RISK
UNDER ITS OWN SUBSECTION (e.g., “5.1 HYPERSENSITIVITY REACTIONS”, “5.2 ELEVATED
LIVER ENZYMES”). FOR EXAMPLE, POTENTIAL LANGUAGE MAY INCLUDE “There are limited
clinical data available for DRUG-X [in XX population, if applicable]. Serious and unexpected
adverse events may occur that have not been previously reported with DRUG-X use.”
6 ADVERSE REACTIONS
FOR THE PURPOSES OF EUAS, AN ADVERSE REACTION IS AN UNDESIRABLE EFFECT,
REASONABLY ASSOCIATED WITH THE USE OF A DRUG THAT MAY OCCUR AS PART OF
THE PHARMACOLOGICAL ACTION OF THE DRUG OR MAY BE UNPREDICTABLE IN ITS
OCCURRENCE. THIS DEFINITION DOES NOT INCLUDE ALL ADVERSE EVENTS OBSERVED
DURING USE OF A DRUG, ONLY THOSE FOR WHICH THERE IS SOME BASIS TO BELIEVE
THERE IS A CAUSAL RELATIONSHIP BETWEEN THE DRUG AND THE OCCURRENCE OF THE
ADVERSE EVENT. DO NOT INCLUDE ADVERSE EVENTS IN WHICH THERE IS NO BASIS TO
BELIEVE THAT THERE IS A CAUSAL RELATIONSHIP BETWEEN DRUG-X AND THE
OCCURRENCE OF THE EVENT.
6.1 Adverse Reactions from Clinical Studies
INCLUDE THE FOLLOWING STATEMENT OR SIMILAR STATEMENT BEFORE THE
PRESENTATION OF THE ADVERSE REACTIONS IN THIS SUBSECTION.
The following adverse reactions have been observed in the clinical studies of DRUG-X that supported
EUA. The adverse reaction rates observed in these clinical studies cannot be directly compared to
rates in the clinical studies of INSERT IF DRUG-X IS ALSO FDA-APPROVED FOR AN
INDICATION: “THE SAME DRUG FOR AN FDA-APPROVED INDICATION OR” another drug and
may not reflect the rates observed in clinical practice.
INCLUDE A DESCRIPTION OF THE OVERALL CLINICAL TRIAL DATABASE FROM WHICH
ADVERSE REACTION DATA HAVE BEEN DRAWN, INCLUDING A DISCUSSION OF OVERALL
EXPOSURE (NUMBER OF PATIENTS, DOSAGE, DURATION), DEMOGRAPHICS OF THE
EXPOSED POPULATION, DESIGNS OF THE TRIALS IN WHICH EXPOSURE OCCURRED (e.g.,
PLACEBO-CONTROLLED), AND ANY CRITICAL EXCLUSIONS FROM THE SAFETY
DATABASE.
INCLUDE A TABLE OF THE ADVERSE REACTIONS IDENTIFIED FROM CLINICAL TRIALS
THAT OCCURRED AT OR ABOVE A SPECIFIED RATE APPROPRIATE TO THE DATABASE
(COMMON ADVERSE REACTIONS TABLE). WITHIN A LISTING, CATEGORIZE ADVERSE
REACTIONS BY BODY SYSTEM, BY SEVERITY OF THE REACTION, OR IN ORDER OF
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DECREASING FREQUENCY, OR BY A COMBINATION OF THESE, AS APPROPRIATE. WITHIN
A CATEGORY, LIST ADVERSE REACTIONS IN DECREASING ORDER OF FREQUENCY.
PRESENT THOSE CLINICALLY SIGNIFICANT ADVERSE REACTIONS THAT OCCURRED
BELOW THE SPECIFIED RATE FOR INCLUSION IN THE COMMON ADVERSE REACTIONS
TABLE, BUT FOR WHICH THERE IS SOME BASIS TO BELIEVE THERE IS A CAUSAL
RELATIONSHIP BETWEEN THE DRUG AND THE EVENT (FOR PURPOSES OF THIS FACT
SHEET, “LESS COMMON” ADVERSE REACTIONS).
6.2 Adverse Reactions from Spontaneous Reports
INCLUDE THE FOLLOWING STATEMENT OR SIMILAR STATEMENT BEFORE THE
PRESENTATION OF THE ADVERSE REACTIONS IN THIS SUBSECTION.
The following spontaneous adverse reactions associated with the use of DRUG-X have been
identified. Because these adverse reactions were reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate their frequency or establish a causal relationship to
drug exposure.
INCLUDE A LIST OF THE ADVERSE REACTIONS, THAT WERE IDENTIFIED FROM DOMESTIC
AND FOREIGN SPONTANEOUS REPORTS.
SUBSECTION 6.4 SHOULD BE MODIFIED FOR THE SPECIFIC DRUG UNDER THE EUA (e.g.,
MAY CONSIDER ADDING REQUIRED REPORTING FOR ADVERSE EVENTS OF SPECIAL
SIGNIFICANCE THAT ARE NOT SERIOUS.
6.3 Required Reporting for Serious Adverse Events and Medication Errors
The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory
reporting of all serious adverse events* and medication errors potentially related to DRUG-X within 7
calendar days from the healthcare provider’s awareness of the event, using FDA Form 3500 (for
information on how to access this form, see below). The FDA requires that such reports, using FDA
Form 3500, include the following:
•
•
•

•
•

Patient demographics and baseline characteristics (e.g., patient identifier, age or date of birth,
gender, weight, ethnicity, and race)
A statement "DRUG-X use for EMERGENCY CONDITION/DISEASE STATE under
Emergency Use Authorization (EUA)” under the “Describe Event, Problem, or Product
Use/Medication Error” heading
Information about the serious adverse event or medication error (e.g., signs and symptoms,
test/laboratory data, complications, timing of drug initiation in relation to the occurrence of the
event, duration of the event, treatments required to mitigate the event, evidence of event
improvement/disappearance after stopping or reducing the dosage, evidence of event
reappearance after reintroduction, clinical outcomes).
Patient’s preexisting medical conditions and use of concomitant products
Information about the product (e.g., dosage, route of administration, NDC #).

Submit adverse event and medication error reports, using Form 3500, to FDA MedWatch using one
of the following methods:
•

Complete and submit the report online: www.fda.gov/medwatch/report.htm

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•

•

Complete and submit a postage-paid FDA Form 3500
(https://www.fda.gov/media/76299/download) and return by:
o Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
o Fax to 1-800-FDA-0178, or
Call 1-800-FDA-1088 to request a reporting form

In addition, please provide a copy of all FDA MedWatch forms to: INCLUDE FIRM’S NAME AND
CONTACT INFORMATION THAT WILL RECEIVE THE MEDWATCH FORMS.
The prescribing healthcare provider and/or the provider’s designee is/are responsible for responses
(INCLUDE MANDATORY RESPONSES IF INCLUDED IN THE EUA LOA.) to requests from FDA for
information about adverse events and medication errors following receipt of DRUG-X.
*Serious adverse events are defined as:
•
•
•
•
•
•

Death;
A life-threatening adverse event;
Inpatient hospitalization or prolongation of existing hospitalization;
A persistent or significant incapacity or substantial disruption of the ability to conduct normal
life functions;
A congenital anomaly/birth defect;
Other important medical event, which may require a medical or surgical intervention to prevent
death, a life-threatening event, hospitalization, disability, or congenital anomaly.

6.5 Other Reporting Requirements (if applicable)
INCLUDE THIS SECTION IF INCLUDED IN THE LOA AS A CONDITION OF AUTHORIZATION
Healthcare facilities and providers will report therapeutics information and utilization data as directed
by the U.S. Department of Health and Human Services.
7 DRUG INTERACTIONS
INCLUDE A DESCRIPTION OF CLINICALLY SIGNIFICANT DRUG INTERACTIONS (OBSERVED
AND PREDICTED) WITH PRESCRIPTION DRUGS, NONPRESCRIPTION DRUGS, FOODS,
BEVERAGES, AND/OR DIETARY SUPPLEMENTS. CONSIDER USING A TABULAR FORMAT.
ALSO INCLUDE THE FOLLOWING:
•
•
•

SPECIFIC PRACTICAL INSTRUCTIONS FOR PREVENTING OR MANAGING CLINICALLY
SIGNIFICANT DRUG INTERACTIONS
MECHANISM OF THE CLINICALLY SIGNIFICANT DRUG INTERACTIONS IF KNOWN
CLINICAL EFFECT(S) OF CLINICALLY SIGNIFICANT DRUG INTERACTIONS

IF DRUG INTERACTIONS HAVE NOT BEEN IDENTIFIED, INCLUDE ONE OF THE FOLLOWING
STATEMENTS: “No drug interactions have been identified based on the limited available data
on the emergency use of DRUG-X authorized under this EUA” or “No clinical drug-drug
interaction trials of DRUG-X with concomitant medications, including other treatments for
EUA AUTHORIZED DISEASE/CONDITION, have been conducted [see Clinical Pharmacology]”

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IF DRUG INTERACTION INFORMATION IS AVAILABLE, INCLUDE THE FOLLOWING
SUBSECTIONS, AS APPROPRIATE.
7.1 Effect of Other Drugs on DRUG-X
7.2 Effect of DRUG-X on Other Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
INCLUDE RISK SUMMARY STATEMENT(S) THAT DESCRIBE, FOR THE DRUG, THE RISK OF
ADVERSE DEVELOPMENTAL OUTCOMES BASED ON ALL RELEVANT HUMAN DATA,
ANIMAL DATA, AND/OR THE DRUG’S PHARMACOLOGY, UNDER THIS HEADING. IF SUCH
ANIMAL AND/OR HUMAN DATA ARE UNAVAILABLE OR INSUFFICIENT, INCLUDE A
STATEMENT NOTING THIS. INCLUDE PREGNANCY REGISTRY INFORMATION, IF
APPLICABLE.
Data
WHEN APPLICABLE, SUMMARIZE THE HUMAN AND/OR ANIMAL DATA THAT SUPPORT THE
RISK SUMMARY STATEMENTS.
8.2 Lactation
Risk Summary
SUMMARIZE INFORMATION ON THE PRESENCE OF A DRUG AND/OR ITS ACTIVE
METABOLITE(S) IN HUMAN MILK, THE EFFECTS OF A DRUG AND/OR ITS ACTIVE
METABOLITE(S) ON THE BREASTFED CHILD, AND THE EFFECTS OF A DRUG AND/OR ITS
ACTIVE METABOLITE(S) ON MILK PRODUCTION. IF THIS INFORMATION IS UNKNOWN,
INCLUDE A STATEMENT NOTING THIS.
IF ONLY ANIMAL LACTATION DATA ARE AVAILABLE, STATE WHETHER OR NOT THE DRUG
AND/OR ITS ACTIVE METABOLITE(S) WERE DETECTED IN ANIMAL MILK. INCLUDE ANY
RECOMMENDATIONS CONCERNING DRUG USE AND BREASTFEEDING.
Data
WHEN APPLICABLE, DESCRIBE THE HUMAN AND/OR ANIMAL DATA ON WHICH THE
LABELING UNDER THE RISK SUMMARY IS BASED. WHEN THE INFORMATION UNDER THE
RISK SUMMARY HEADING IS BASED ON HUMAN DATA, ANIMAL DATA MUST NOT BE
INCLUDED UNLESS THE ANIMAL MODEL IS SPECIFICALLY KNOWN TO BE PREDICTIVE FOR
HUMANS.
8.3 Females and Males of Reproductive Potential
IF APPLICABLE, INCLUDE THIS SUBSECTION IF THERE ARE RECOMMENDATIONS FOR
PREGNANCY TESTING AND/OR CONTRACEPTION BEFORE, DURING, OR AFTER DRUG
THERAPY, AND/OR (2) THERE ARE HUMAN AND/OR ANIMAL DATA SUGGESTING DRUGASSOCIATED EFFECTS ON FERTILITY AND/OR PRE-IMPLANTATION LOSS EFFECTS.
INCLUDE THE INFORMATION UNDER THE FOLLOWING HEADINGS, WHEN APPLICABLE.
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Pregnancy Testing
Contraception
Females
Males
Infertility
Females
Males
8.4 Pediatric Use
CLEARLY STATE IF AN EUA WAS GRANTED OR NOT GRANTED IN ALL PEDIATRIC AGE
GROUPS.
IF AN EUA WAS GRANTED IN A PEDIATRIC SUBPOPULATION, INCLUDE THE
FOLLOWING STATEMENT OR SIMILAR STATEMENT:
The FDA has issued an EUA for the emergency use of DRUG-X for EUA AUTHORIZED USE in
INCLUDE AUTHORIZED PEDIATRIC POPULATION. However, DRUG-X is not approved for this
use.
IF AN EUA WAS NOT GRANTED IN A PEDIATRIC SUBPOPULATION, INCLUDE THE
FOLLOWING STATEMENT OR SIMILAR STATEMENT:
DRUG-X is not authorized or approved for the emergency use for INCLUDE EUA AUTHORIZED
DISEASE/CONDITION in INCLUDE UNAUTHORIZED PEDIATRIC SUBPOPULATION.
INCLUDE SPECIFIC RISKS OR SAFETY CONCERNS IN PEDIATRIC PATIENTS AND/OR NEED
FOR SPECIFIC MONITORING, ANY LIMITATIONS ON PEDIATRIC AUTHORIZED USE, AND ANY
DIFFERENCES BETWEEN THE EFFECTIVENESS AND SAFETY OF DRUG-X IN PEDIATRIC
AND ADULT PATIENTS.
8.5 Geriatric Use
INCLUDE THE NUMBER AND PERCENTAGE OF DRUG-X-TREATED AND CONTROL-TREATED
GERIATRIC PATIENTS (PATIENTS 65 YEARS OF AGE AND OLDER) IN THE CLINICAL
STUDIES. IF DATA IS AVAILABLE, INCLUDE ADDITIONAL EXPOSURE DATA IN GERIATRIC
SUBPOPULATIONS (e.g., 65 TO 74 YEARS OF AGE, 75 TO 84 YEARS OF AGE, AND 85 YEARS
OF AGE AND OLDER) IF APPROPRIATE.
•

IF THERE IS INSUFFICIENT DATA TO DETECT DIFFERENCES IN SAFETY AND/OR
EFFECTIVENESS BETWEEN GERIATRIC PATIENTS AND YOUNGER ADULT PATIENTS,
THEN STATE: “CLINICAL STUDIES OF DRUG-X DID NOT INCLUDE SUFFICIENT
NUMBERS OF PATIENTS 65 YEARS OF AGE AND OLDER TO DETERMINE WHETHER
THEY RESPOND DIFFERENTLY FROM YOUNGER ADULT PATIENTS.” INCLUDE
SPECIFIC RISKS OR SAFETY CONCERNS ASSOCIATED WITH THE USE OF DRUG-X IN
GERIATRIC PATIENTS AND SPECIFIC RISK MITIGATION IN GERIATRIC PATIENTS.

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•

•

IF THERE IS SUFFICIENT DATA TO DETECT DIFFERENCES IN SAFETY AND/OR
EFFECTIVENESS BETWEEN GERIATRIC PATIENTS AND YOUNGER ADULT PATIENTS,
BUT NO OVERALL DIFFERENCES WERE OBSERVED, THEN STATE: “NO OVERALL
DIFFERENCES IN SAFETY OR EFFECTIVENESS OF DRUG-X HAVE BEEN OBSERVED
BETWEEN PATIENTS 65 YEARS OF AGE AND OLDER AND YOUNGER ADULT
PATIENTS.”
IF THERE IS SUFFICIENT DATA TO DETECT DIFFERENCES IN SAFETY AND/OR
EFFECTIVENESS BETWEEN GERIATRIC PATIENTS AND YOUNGER ADULT PATIENTS ,
THEN DESCRIBE THESE DIFFERENCES AND PROVIDE INFORMATION ON RISK
MITIGATION IN GERIATRIC PATIENTS.

8.6 Subpopulation X
INCLUDE ADDITIONAL SUBSECTIONS (AFTER SUBSECTION 8.5 GERIATRIC USE) IF
SUFFICIENT DATA ARE AVAILABLE CONCERNING USE OF DRUG IN OTHER SPECIFIED
SUBPOPULATIONS (e.g., 8.6 RENAL IMPAIRMENT, 8.7 HEPATIC IMPAIRMENT).
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
IN ADDITION TO THE EUA USE, IF THE DRUG IS APPROVED FOR A USE AND IS SCHEDULED
UNDER THE CONTROLLED SUBSTANCES ACT, STATE THAT THE DRUG IS A CONTROLLED
SUBSTANCE AND IDENTIFY THE SCHEDULE UNDER WHICH THE DRUG IS CONTROLLED.
9.2 Abuse
INCLUDE, AS APPROPRIATE, INFORMATION ABOUT THE DRUG RELATED TO ABUSE,
MISUSE, AND ADDICTION THAT IS IMPORTANT FOR HEALTHCARE PRACTITIONERS TO
CONSIDER.
9.3 Dependence
INCLUDE INFORMATION ABOUT THE DRUG RELATED TO PHYSICAL DEPENDENCE,
WITHDRAWAL, AND TOLERANCE. SUMMARIZE SIGNS AND SYMPTOMS OF WITHDRAWAL
AFTER CHRONIC USE OR ABUSE OF THE DRUG IN THE DEPENDENCE SUBSECTION,
WHEREAS DISCUSS ABUSE-RELATED ADVERSE REACTIONS IN THE ABUSE SUBSECTION.
10 OVERDOSAGE
IF APPLICABLE, DESCRIBE SIGNS, SYMPTOMS, AND LABORATORY FINDINGS OF
OVERDOSAGE, COMPLICATIONS THAT CAN OCCUR WITH OVERDOSAGE (e.g., ORGAN
TOXICITY), THE AMOUNT OF DRUG IN A SINGLE DOSE THAT IS ASSOCIATED WITH
SYMPTOMS OF OVERDOSAGE, THE AMOUNT OF DRUG IN A SINGLE DOSE THAT IS LIKELY
TO BE LIFE-THREATENING, AND GENERAL TREATMENT PROCEDURES AND SPECIFIC
MEASURES FOR SUPPORT OF VITAL FUNCTIONS DURING AN OVERDOSAGE.
11 DESCRIPTION
INCLUDE THE DRUG NAME(S), DOSAGE FORM(S), ROUTE(S) OF ADMINISTRATION,
PHARMACOLOGIC OR THERAPEUTIC CLASS, QUALITATIVE AND QUANTITATIVE
INGREDIENT INFORMATION. ADDITIONALLY, FOR DRUG PRODUCTS, INCLUDE THE
CHEMICAL NAME AND STRUCTURAL FORMULA.

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12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
SUMMARIZE WHAT IS KNOWN ABOUT THE MECHANISM(S) OF ACTION OF THE DRUG (1)
FOR THE EUA AUTHORIZED USE AND (2) FOR THE CLINICALLY SIGNIFICANT ADVERSE
REACTIONS ASSOCIATED WITH THE DRUG. IF THE MECHANISM OF ACTION FOR THE
AUTHORIZED USE IS UNKNOWN, INCLUDE A STATEMENT ABOUT THE LACK OF THIS
INFORMATION. PROMOTIONAL LANGUAGE SHOULD BE AVOIDED.
12.2 Pharmacodynamics
DESCRIBE THE BIOCHEMICAL OR PHYSIOLOGIC PHARMACOLOGIC EFFECTS OF THE
DRUG AND/OR ACTIVE METABOLITES RELATED TO THE DRUG’S AUTHORIZED USE OR
RELATED TO THE CLINICALLY SIGNIFICANT ADVERSE REACTIONS ASSOCIATED WITH THE
USE OF THE DRUG.
12.3 Pharmacokinetics
AT THE BEGINNING OF THIS SUBSECTION, PROVIDE A BRIEF INTRODUCTION THAT
DESCRIBES THE GENERAL, CLINICALLY SIGNIFICANT PHARMACOKINETIC PROPERTIES
OF THE PARENT DRUG AND ITS RELEVANT METABOLITES, AND ANY UNIQUE DRUG
CHARACTERISTICS. INCLUDE THE FOLLOWING HEADINGS AND SUBHEADINGS, IF
RELEVANT.
Absorption
Effect of Food
Distribution
Elimination
Metabolism
Excretion
Specific Populations
Geriatric Patients
Pediatric Patients
Male and Female Patients
Racial or Ethnic Groups
Patients with Renal Impairment
Patients with Hepatic Impairment
Pregnant Women
Drug Interaction Studies
Drug A
Drug B

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12.4 Microbiology
INCLUDE INFORMATION RELEVANT TO THE MICROBIOLOGY CHARACTERISTICS OF THE
DRUG.
12.5 Pharmacogenomics
INCLUDE CLINICALLY RELEVANT DATA OR INFORMATION ON THE EFFECT OF GENETIC
VARIATIONS AFFECTING DRUG THERAPY.
12.6 Immunogenicity
INCLUDE THIS SUBSECTION IF THE DRUG HAS HAD AN IMMUNOGENICITY ASSESSMENT.
IF THE METHODOLOGY FOR THE SUBMITTED IMMUNOGENICITY EVALUATION IS
ADEQUATE SUCH THAT IT ALLOWS FOR AN ASSESSMENT OF ANTI-DRUG-ANTIBODY (ADA)
INCIDENCE INCLUDE THE FOLLOWING:
•

INCLUDE THE FOLLOWING PARAGRAPH AT THE BEGINNING OF THIS SUBSECTION,
PRECEDING THE IMMUNOGENICITY DATA:
“THE OBSERVED INCIDENCE OF ANTI-DRUG ANTIBODIES IS HIGHLY DEPENDENT
ON THE SENSITIVITY AND SPECIFICITY OF THE ASSAY. DIFFERENCES IN ASSAY
METHODS PRECLUDE MEANINGFUL COMPARISONS OF THE INCIDENCE OF ANTIDRUG ANTIBODIES IN THE STUDIES DESCRIBED BELOW WITH THE INCIDENCE OF
ANTI-DRUG ANTIBODIES IN OTHER STUDIES, INCLUDING THOSE OF [INSERT
PROPER NAME, ACTIVE MOIETY NAME, OR ACTIVE INGREDIENT NAME] OR OF
OTHER [INSERT CORE NAME, ACTIVE MOIETY NAME, OR ACTIVE INGREDIENT
NAME] PRODUCTS.”

•

REPORT THE INCIDENCE OF ADA, INCLUDING NEUTRALIZING ANTIBODIES, ALONG
WITH DURATION OF EXPOSURE TO THE DRUG AND TIME PERIOD OVER WHICH
SAMPLING FOR ADA WAS CONDUCTED.

•

SUMMARIZE THE KNOWN EFFECT(S) OF ADA ON THE PHARMACOKINETICS AND
PHARMACODYNAMICS UNDER THE HEADINGS ANTI-DRUG ANTIBODY EFFECTS ON
PHARMACOKINETICS AND ANTI-DRUG ANTIBODY EFFECTS ON
PHARMACODYNAMICS, RESPECTIVELY.

IF THE METHODOLOGY FOR THE SUBMITTED IMMUNOGENICITY EVALUATION IS
INADEQUATE, SUCH THAT IT PRECLUDES AN ASSESSMENT OF THE INCIDENCE OF ADA,
INCLUDE THE FOLLOWING OR SIMILAR STATEMENT IN THIS SUBSECTION:
“THERE IS INSUFFICIENT INFORMATION TO CHARACTERIZE THE ANTI-DRUG
ANTIBODY RESPONSE OF [INSERT PROPER NAME, ACTIVE MOIETY NAME, OR ACTIVE
INGREDIENT NAME] AND THE EFFECTS OF ANTI-DRUG ANTIBODIES ON
PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY, OR EFFECTIVENESS OF
OTHER [INSERT CORE NAME, ACTIVE MOIETY NAME, OR ACTIVE INGREDIENT NAME]
PRODUCTS.”
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
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INCLUDE INFORMATION ON ANIMAL STUDIES/MODELS ABOUT THE CARCINOGENIC
POTENTIAL, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY OF THE DRUG.
13.2 Animal Toxicology and/or Pharmacology
INCLUDE INFORMATION ABOUT SIGNIFICANT ANIMAL DATA THAT IS NOT INCORPORATED
IN OTHER SECTIONS OF THIS FACT SHEET.
14 CLINICAL STUDIES
DISCUSS THE CLINICAL STUDIES THAT ARE IMPORTANT TO A HEALTHCARE
PRACTITIONER’S UNDERSTANDING OF THE EMERGENCY USE OF DRUG-X FOR THE
AUTHORIZED USE. TYPICALLY, THIS SECTION SHOULD INCLUDE A DESCRIPTION AND
RESULTS OF THE CLINICAL STUDIES THAT PROVIDED THE PRIMARY SUPPORT FOR THE
AUTHORIZATION. INCLUDE INFORMATION ABOUT CLINICAL STUDIES THAT SUGGEST A
LACK OF SUPPORT AND REASONING FOR LACK OF SUPPORT OF AN EFFECT IN A
CLINICAL SITUATION OR LACK OF EFFECT ON AN ENDPOINT.
INCLUDE STUDY DESIGN CHARACTERISTICS, INCLUDING:
•
•
•
•
•

MAJOR DESIGN CHARACTERISTICS
STUDY TREATMENT ARMS, INCLUDING DOSING REGIMENS AND TITRATIONS
IMPORTANT ELIGIBILITY CRITERIA FOR UNDERSTANDING THE TREATMENT EFFECT
IMPORTANT CONCOMITANT THERAPY THAT HELPS UNDERSTAND THE EFFECTS OF
THE DRUG
ENDPOINTS CRITICAL TO ESTABLISH THE AUTHORIZED USE, AND IMPORTANT
LIMITATIONS OF THE STUDIES

WHEN SUMMARIZING STUDY FINDINGS INCLUDE:
•
•
•
•
•

NUMBER ENROLLED
IMPORTANT BASELINE DISEASE CHARACTERISTICS AND DEMOGRAPHICS
IMPORTANT FOR UNDERSTANDING THE TREATMENT EFFECT OR FOR
UNDERSTANDING IF THE RESULTS CAN BE GENERALIZED
ENDPOINT RESULTS THAT ARE FOUND TO BE BOTH STATISTICALLY AND
CLINICALLY SIGNIFICANT OR SUGGESTED A LACK OF SUPPORT OF AN EFFECT
CONFIDENCE INTERVALS EVEN IF P-VALUES ARE PRESENTED
SUMMARY STATEMENT ABOUT EFFECTS IN DEMOGRAPHIC SUBGROUPS (E.G., AGE,
GENDER, RACIAL SUBGROUPS) OR IMPORTANT BASELINE DISEASE
CHARACTERISTICS (E.G., GENETIC DIFFERENCES) WHEN THE SUBGROUP WAS
APPROPRIATELY PRE-SPECIFIED AND THE SUBGROUP SAMPLE SIZE HAD A
REASONABLE ABILITY TO DETECT SUBGROUP DIFFERENCES. INCLUDE
LIMITATIONS OF SUBGROUP ANALYSES, E.G., “HOWEVER, THESE SUBGROUP
EXPLORATORY ANALYSES WERE NOT CONTROLLED FOR MULTIPLE
COMPARISONS.” STATE WHEN SUBGROUP ANALYSES ARE INADEQUATE FOR
ASSESSING THE EFFECTS IN PARTICULAR SUBGROUPS.

DO NOT INCLUDE ANY INFORMATION THAT IMPLIES OR SUGGESTS EUA USES OR
DOSAGES THAT ARE NOT AUTHORIZED IN SECTIONS 1 OR 2 OF THIS FACT SHEET,
RESPECTIVELY.
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15 REFERENCES
THIS SECTION IS USUALLY OMITTED, UNLESS THERE ARE AUTHORITATIVE REFERENCES
IMPORTANT TO PRESCRIBING DECISIONS THAT ARE MENTIONED IN ANOTHER SECTION
OF THIS FACT SHEET BUT CANNOT READILY BE SUMMARIZED.
16 HOW SUPPLIED/STORAGE AND HANDLING
INCLUDE INFORMATION ABOUT THE DOSAGE FORM(S), STRENGTH(S), UNITS IN WHICH
THE DOSAGE FORM IS ORDINARY AVAILABLE (e.g., BOTTLES OF 100), IDENTIFYING
CHARACTERISTICS OF THE DOSAGE FORM(S), SPECIAL HANDLING, AND STORAGE
CONDITIONS OF THE SUPPLIED PRODUCT (e.g., REFRIGERATE, DO NOT FREEZE).
17 PATIENT COUNSELING INFORMATION
As a healthcare practitioner, you must provide a copy of the “FACT SHEET FOR PATIENTS AND
PARENTS/CAREGIVERS” and communicate to the patient and/or caregiver information consistent
with the fact sheet prior to administration of DRUG-X. OPTIONAL STATEMENT FOR PRODUCT
USE IN LIFE-THREATENING SITUATIONS: However, if providing this information will delay the
administration of DRUG-X to a degree that would endanger the life of a patient, the information must
be provided to the parent and/or caregiver as soon as feasible after DRUG-X administration.
18 MANUFACTURER INFORMATION
FOR DRUG 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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