Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry: Draft Guidance for Industry

Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

33150061dft.docx
9/8/2020
Geriatric Information in
Human Prescription Drug
and Biological Product
Labeling
Guidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit electronic comments to https://www.regulations.gov. Submit written
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the
docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document, contact (CDER) Eric Brodsky at 301-796-0855, or
(CBER) the Office of Communication, Outreach, and Development at 800-835-4709 or 240-402-
8010.
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)
September 2020
Labeling

Geriatric Information in
Human Prescription Drug
and Biological Product
Labeling
Guidance for Industry
Additional copies are available from:
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Center for Drug Evaluation and Research
Food and Drug Administration
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Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: druginfo@fda.hhs.gov
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and/or
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https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances
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)
September 2020
Labeling

Contains Nonbinding Recommendations
Draft – Not for Implementation
TABLE OF CONTENTS
I. 	INTRODUCTION............................................................................................................. 1
II. 	BACKGROUND ............................................................................................................... 2
A. 	Geriatric Initiatives........................................................................................................................ 2
1. Geriatric Clinical Data Initiatives ................................................................................................... 2
2. Geriatric Labeling Initiatives .......................................................................................................... 3
B. 	Geriatric Population in Labeling .................................................................................................. 3
III. 	OVERVIEW OF GERIATRIC USE INFORMATION IN HUMAN
PRESCRIPTION DRUG AND BIOLOGICAL PRODUCT LABELING .................. 4
IV. 	DRUG IS APPROVED FOR USE GENERALLY IN ADULT PATIENTS
INCLUDING GERIATRIC PATIENTS OR A SUBSET OF THE GERIATRIC
POPULATION (SCENARIOS 1.1, 1.2, AND 1.3) ......................................................... 5
A. 	Including Information in the Geriatric Use Subsection of Labeling (Scenarios 1.1, 1.2, and
1.3) ................................................................................................................................................... 5
1. When Information Is Sufficient to Detect Differences in Safety and/or Effectiveness Between
Geriatric and Younger Adult Patients — Geriatric Use Subsection (Scenarios 1.1 and 1.2) ......... 7
a. 	No observed differences in safety and/or effectiveness in geriatric patients compared to
younger adult patients (scenario 1.1) ........................................................................................ 8
b. 	Differences in safety and/or effectiveness in geriatric patients compared to younger adult
patients (scenario 1.2) ............................................................................................................... 9
2. When Information Is Insufficient to Detect Differences in Safety and/or Effectiveness Between
Geriatric and Younger Adult Patients — Geriatric Use Subsection (Scenario 1.3) ...................... 10
3. Additional Required and Recommended Information in the Geriatric Use Subsection (Scenarios
1.1, 1.2, and 1.3) ............................................................................................................................ 11
a. 	Specific risks or safety concerns in geriatric patients — Geriatric Use subsection (scenarios
1.1, 1.2, and 1.3)...................................................................................................................... 11
b. 	Summarizing specific pharmacokinetic or pharmacodynamic studies in geriatric patients —
Geriatric Use subsection (scenarios 1.1, 1.2, and 1.3)............................................................ 12
c. 	When a drug is known to be substantially excreted by the kidney — Geriatric Use subsection
(scenarios 1.1, 1.2, and 1.3) .................................................................................................... 12
B. 	Including Geriatric Use Information in Other Sections of Labeling (Scenarios 1.1, 1.2,
and/or 1.3) ..................................................................................................................................... 14
V. 	DRUG IS APPROVED FOR A GERIATRIC-SPECIFIC INDICATION
(SCENARIO 2) ................................................................................................................ 15
VI. 	DRUG IS NOT APPROVED IN THE GERIATRIC POPULATION ...................... 16
VII. 	OMITTING OR REVISING INFORMATION AND UPDATING LABELING..... 17

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1
Geriatric Information in Human Prescription	1
Drug and Biological Product Labeling	2
Guidance for Industry1
3
4
5
6
This draft guidance, when finalized, will represent the current thinking of the Food and Drug	7
Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not	8
binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the	9
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible	10
for this guidance as listed on the title page.	11
12
13
14
I. 	INTRODUCTION	15
16
This guidance is intended to assist applicants of human prescription drug and biological	17
products2 in determining the appropriate placement and content of geriatric information in	18
labeling as described in the regulations for the content and format of labeling for human	19
prescription drug and biological products.3,4	
20
21
The goal of this guidance is to provide recommendations to help ensure that appropriate	22
information on the use of prescription drugs in geriatric patients is consistently placed in the	23
proper sections and subsections within labeling so that the information is clear and accessible to	24
health care practitioners and includes content that guides the safe and effective use in geriatric	25
patients.	26
27
This guidance, which replaces the withdrawn guidance for industry Content and Format for	28
Geriatric Labeling (October 2001), provides additional examples of geriatric use statements in	29
labeling and examples of when the labeling regulations authorize the FDA to permit applicants to	30
omit or revise specific information otherwise required in the Geriatric Use subsection.	31
32
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.	33
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only	34
as recommendations, unless specific regulatory or statutory requirements are cited. The use of	35
1 This guidance has been prepared by the Labeling Policy Team in the Center for Drug Evaluation and Research in
cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration.
2 For the purposes of this guidance, references to drugs and drug and biological products include drugs approved
under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products licensed
under section 351 of the Public Health Service Act (42 U.S.C. 262) that are regulated as drugs.
3 See 21 CFR 201.56(d) and 21 CFR 201.57.
4 This guidance does not pertain to labeling for nonprescription drugs.

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the word should in Agency guidances means that something is suggested or recommended, but	36
not required.	37
38
39
II. 	BACKGROUND	40
41
A. 	Geriatric Initiatives	42
43
1. 	Geriatric Clinical Data Initiatives	44
45
In the 1980s, the FDA began several initiatives to increase the quantity and quality of	46
information about the use of drugs in geriatric patients (defined as patients 65 years of age and	47
older) so that health care practitioners would have enough information for the safe and effective	48
use of drugs in geriatric patients. For example, the FDA encourages a thorough evaluation of the	49
effectiveness and safety of drugs in geriatric patients and recommends examination of age-	50
related differences in effectiveness, dose response, and safety.5 In 1998, the FDA required new	51
drug application (NDA) holders6 and, subsequently, recommended that biologics license	52
application (BLA) holders7 present in their applications effectiveness and safety data based on	53
age. In 2012, in an International Conference on Harmonisation (ICH) guidance for industry, the	54
FDA reaffirmed the importance of obtaining geriatric data, across the entire full age range of the	55
geriatric population because of the likelihood of comorbidities and the increasing number of	56
geriatric patients in the United States.8 The guidance also noted ways in which geriatric patients	57
(especially patients 75 years of age and older) may respond differently to drug therapy than	58
younger adult patients.9	
59
60
In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) directed the	61
FDA to report on the inclusion of demographic subgroups (including age subgroups) in clinical	62
5 See the guidance for industry Guideline for the Study of Drugs Likely to Be Used in the Elderly (November 1989)
and the International Conference on Harmonisation guidance for industry E7 Studies in Support of Special
Populations: Geriatrics (August 1994). 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/regulatory-information/search-fda-
guidance-documents.
6 See the preamble of the demographic rule (21 CFR 314.50(d)(5); 63 FR 6854) published February 11, 1998. In
addition to age, NDA holders are required to present effectiveness and safety data in other important demographic
groups in their NDAs.
7 See the guidance for industry and FDA staff Collection of Race and Ethnicity Data in Clinical Trials (October
2016). In addition to age, the FDA recommends that BLA holders present effectiveness and safety data in other
important demographic groups in their BLAs.
8 See the ICH guidance for industry E7 Studies in Support of Special Populations: Geriatrics: Questions and
Answers (February 2012).
9 Ibid.

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studies and the analysis of these demographic subgroups (including age subgroups) in NDAs and	63
BLAs.10	
64
65
2. 	Geriatric Labeling Initiatives	66
67
Until the late 1990s, the majority of drug labeling contained minimal or no geriatric use	68
information to guide safe and effective use in the geriatric population. In 1997, the FDA issued a	69
final rule creating a Geriatric Use subsection of labeling to promote the consistent inclusion of	70
all relevant geriatric information in labeling.11 This subsection is intended to provide	71
information on possible differences in the safety, effectiveness, pharmacodynamics, and/or	72
pharmacokinetics between geriatric and younger adult patients given differences in responses,	73
drug elimination, comorbidities, organ function (e.g., renal function), consequences of adverse	74
reactions, and concomitant therapy (e.g., higher risk of drug interactions because of	75
polypharmacy).	76
77
In 2001, the FDA issued the now-withdrawn guidance for industry Content and Format for	78
Geriatric Labeling, which provided recommendations for the Geriatric Use subsection in the	79
PRECAUTIONS section. In 2006, the FDA issued the final rule “Requirements on Content and	80
Format of Labeling for Human Prescription Drug and Biological Products” (commonly referred	81
to as the physician labeling rule (PLR)), which relocated the Geriatric Use subsection from the	82
PRECAUTIONS section in old (non-PLR) format labeling to the USE IN SPECIFIC	83
POPULATIONS section for labeling required to be in PLR format.12	
84
85
B. 	Geriatric Population in Labeling	86
87
In general, for prescription drug labeling, the adult population is defined as patients 17 years of	88
age and older, and the geriatric population is defined as patients 65 years of age and older.13	
89
Therefore, information in labeling that is pertinent to the adult population is typically also	90
pertinent to the geriatric population (e.g., indications approved in adults include geriatric	91
patients).14	
92
93
10 See section 907 of FDASIA.
11 See the preamble of the final rule, “Specific Requirements on Content and Format of Labeling for Human
Prescription Drugs; Addition of ‘Geriatric Use’ Subsection in the Labeling,” (21 CFR 201; 62 FR 45313) published
August 27, 1997, section II.A.
12 See the preamble of the final rule, “Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products,” (21 CFR parts 201, 314, and 601; 71 FR 3922) published January 24, 2006.
13 21 CFR 201.57(c)(9)(iv)(A) and 21 CFR 201.57(c)(9)(v)(A).
14 See the draft guidance for industry Indications and Usage Section of Labeling for Human Prescription Drug and
Biological Products — Content and Format (July 2018). When final, this guidance will represent the FDA’s current
thinking on this topic.

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The information in the Geriatric Use subsection must pertain to the use of the drug in patients 65	94
years of age and older, unless otherwise noted.15 Patients 65 years of age and older are not a	95
homogeneous group (e.g., differences in organ function, comorbidities, concomitant drugs, and	96
drug distribution and elimination). Applicants should include information on additional geriatric	97
age subgroups in the labeling if important differences exist in responses in these subgroups.16	
98
Such subgroups should be further defined in the labeling as appropriate (e.g., 65-74 years of age;	99
75-84 years of age; and 85 years of age and older).17 In some cases, geriatric age might be	100
expressed as a continuous function of age.18	
101
102
103
III. 	OVERVIEW OF GERIATRIC USE INFORMATION IN HUMAN	104
PRESCRIPTION DRUG AND BIOLOGICAL PRODUCT LABELING	105
106
In general, applicants must summarize certain geriatric use information in the Geriatric Use	107
subsection19 and, when appropriate, must cross-reference the appropriate section(s) or	108
subsection(s) of labeling that provide more detailed geriatric use information.20 Certain geriatric	109
use information must be included based on the type of information being conveyed,21 which can	110
be characterized as follows:	111
112
15 21 CFR 201.57(c)(9)(v)(A). See also the preamble of the final rule, “Specific Requirements on Content and
Format of Labeling for Human Prescription Drugs; Addition of ‘Geriatric Use’ Subsection in the Labeling,” (21
CFR 201; 62 FR 45313, 45316) published August 27, 1997, stating that the Agency “does not consider 65 years of
age to be an absolute” age cut-off to define geriatric patients in labeling. For some labeling, it may be more
appropriate to choose a different age cut-off to define geriatric patients.
16 See the preamble of the final rule, “Specific Requirements on Content and Format of Labeling for Human
Prescription Drugs; Addition of ‘Geriatric Use’ Subsection in the Labeling,” (21 CFR 201; 62 FR 45313, 45316)
published August 27, 1997.
17 The FDA recommends that the age distribution in the clinical development program be representative of the target
population, and that applications should assess the consistency of the treatment effect and safety profile in geriatric
subpopulations (e.g., 65–74 years of age, 75–84 years of age, and 85 years of age and older) and younger adults.
See the guidance for industry E7 Studies in Support of Special Populations: Geriatrics: Questions and Answers.
18 See the preamble of the final rule, “Specific Requirements on Content and Format of Labeling for Human
Prescription Drugs; Addition of ‘Geriatric Use’ Subsection in the Labeling,” (21 CFR 201; 62 FR 45313, 45316)
published August 27, 1997.
19 See 21 CFR 201.57(c)(9)(v). The FDA may permit omission of required statement(s) in the Geriatric Use
subsection if the FDA determines that no statement described in 21 CFR 201.57(c)(9)(v)(A) to (E) is appropriate or
relevant to the drug’s labeling; additionally, the FDA may permit an alternative appropriate and accurate
statement(s) (21 CFR 201.57(c)(9)(v)(F)).
20 21 CFR 201.57(c)(9)(v)(B)(3) and 21 CFR 201.57(c)(9)(v)(D). Additional cross-references from the Geriatric
Use subsection to other section(s)/subsection(s) are recommended when there is more detailed geriatric use
information in those other section(s)/subsection(s). See the guidance for industry Labeling for Human Prescription
Drug and Biological Products — Implementing the PLR Content and Format Requirements (February 2013).
21 See 21 CFR 201.57(c)(9)(v).

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113
• 	Three scenarios (i.e., scenarios 1.1, 1.2, and 1.3) in which the drug is approved for use in	114
adult patients generally, including geriatric patients or a subset of the geriatric	115
population:	116
117
− 	Scenario 1.1: When information is sufficient to detect differences in safety and/or	118
effectiveness between geriatric and younger adult patients and there were no observed	119
differences in safety and/or effectiveness between these groups22	
120
121
− 	Scenario 1.2: When information is sufficient to detect differences in safety and/or	122
effectiveness between geriatric and younger adult patients and differences in safety	123
and/or effectiveness between these groups were observed23	
124
125
− 	Scenario 1.3: When information is insufficient to detect differences in safety and/or	126
effectiveness between geriatric and younger adult patients24	
127
128
• 	Scenario 2 in which the drug is approved for a geriatric-specific indication25 (i.e., for a	129
specific indication, the drug is indicated for use only in geriatric patients (or a subset of	130
the geriatric population) and not in adult patients less than 65 years old).	131
132
The following sections provide more detailed descriptions of scenarios 1.1, 1.2, 1.3, and 2 and	133
geriatric information that is required or recommended for inclusion in relevant sections and	134
subsections of labeling.	135
136
137
IV. 	DRUG IS APPROVED FOR USE GENERALLY IN ADULT PATIENTS	138
INCLUDING GERIATRIC PATIENTS OR A SUBSET OF THE GERIATRIC	139
POPULATION (SCENARIOS 1.1, 1.2, AND 1.3)	140
141
A. 	Including Information in the Geriatric Use Subsection of Labeling (Scenarios	142
1.1, 1.2, and 1.3)	143
144
The Geriatric Use subsection must include certain information pertinent to the safe and effective	145
use of the drug in geriatric patients for all indications approved for use in adult patients	146
(including geriatric patients).26	
147
148
22 21 CFR 201.57(c)(9)(v)(B)(2).
23 21 CFR 201.57(c)(9)(v)(B)(3).
24 21 CFR 201.57(c)(9)(v)(B)(1).
25 21 CFR 201.57(c)(9)(v)(A).
26 21 CFR 201.57(c)(9)(v)(B).

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Information in this subsection is typically derived from results from controlled clinical studies	149
submitted in the application or supplement(s) that are relevant to the use of the drug in geriatric	150
patients. However, sometimes information in this subsection is obtained from “other reported	151
clinical experience”27 such as, but not limited to, well-documented studies obtained from a	152
literature search, clinically relevant information from registries, other epidemiological or	153
surveillance studies, case series studies, and adverse event reports.28	
154
155
Under scenario 1.1, the Geriatric Use subsection must include the percentage of patients 65	156
years of age and older and the percentage of patients 75 years of age and older (or the total	157
number of patients 65 years of age and older and the total number of patients 75 years of age and	158
older) in the clinical studies of the drug.29 Under this scenario, to provide more information to	159
health care practitioners about geriatric exposure, the FDA recommends that this subsection	160
present both the number and percentage of drug-exposed patients 65 years of age and older, and	161
the number and percentage of drug-exposed patients 75 years of age and older in a defined group	162
of clinical studies (typically the clinical studies that supported the approval of the drug in adult	163
patients, including geriatric patients). Under scenario 1.1, alternative age cutoff point(s) within	164
the geriatric population may be permitted to describe drug exposure, if the FDA determines that	165
such age cutoff point(s) are accurate and appropriate.30	
166
167
Under scenarios 1.2 and 1.3, the FDA recommends including geriatric exposure information in	168
the Geriatric Use subsection. Specifically, we recommend that this subsection provide both the	169
number and percentage of drug-exposed geriatric patients in a defined group of clinical studies	170
(typically the clinical studies that supported the approval of the drug in adult patients, including	171
geriatric patients). Different age cutoff points within the geriatric population can be selected to	172
describe drug exposure, depending on the database (see section II.B., Geriatric Population in	173
Labeling, in this guidance).	174
175
Under scenarios 1.1, 1.2, and 1.3, the Geriatric Use subsection can also include information on	176
the total number of geriatric patients in the clinical studies (e.g., including drug-treated patients	177
and control-treated patients). Under these scenarios, we recommend that this subsection cross-	178
reference to other sections of labeling that contain additional details about the studies used to	179
determine the geriatric exposure (e.g., the CLINICAL STUDIES section).	180
181
In general, geriatric exposure information should be placed at the beginning of the Geriatric Use	182
subsection. However, information on specific risks or safety concerns associated with the use of	183
the drug in geriatric patients and/or recommendations on specific monitoring in geriatric patients	184
may appear before the drug exposure information.	185
186
27 21 CFR 201.57(c)(9)(v)(B)(1), (2), and (3).
28 See the preamble of the final rule, “Specific Requirements on Content and Format of Labeling for Human
Prescription Drugs; Addition of ‘Geriatric Use’ Subsection in the Labeling,” (21 CFR 201; 62 FR 45313) published
August 27, 1997.
29 21 CFR 201.57(c)(9)(v)(B)(2).
30 21 CFR 201.57(c)(9)(v)(F).

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The following examples represent options for summarizing geriatric exposure information under	187
scenarios 1.1, 1.2, and/or 1.3; alternative language can be proposed.	188
189
• 	Example 1:	190
191
“There were n patients 65 years of age and older in the clinical studies for Disease A [see	192
Clinical Studies (14)]. Of the total number of DRUG X-treated patients in these studies,	193
n (y%) were 65 years of age and older, while n (z%) were 75 years of age and older.”	194
195
• 	Example 2:	196
197
“Of the total number of DRUG X-treated patients in clinical studies for Disease A, n	198
(y%) were 65 to 74 years of age, and n (z%) were 75 years of age and older [see Clinical	199
Studies (14)].”	200
201
• 	Example 3:	202
203
“There were n patients 65 years of age and older in the clinical studies for Disease A,	204
Disease B, and Disease C [see Clinical Studies (14.1, 14.2, 14.3)]. Of the total number	205
of DRUG X-treated patients in these studies, n (x%) were 65 to 74 years of age, n (y%)	206
were 75 to 84 years of age, and n (z%) were 85 years of age and older.”	207
208
1. 	When Information Is Sufficient to Detect Differences in Safety and/or	209
Effectiveness Between Geriatric and Younger Adult Patients — Geriatric Use	210
Subsection (Scenarios 1.1 and 1.2)	211
212
Factors that can affect whether there is sufficient information to detect differences in safety or	213
effectiveness between geriatric and younger adult patients include the numbers of geriatric	214
patients treated with the drug and control compared with the numbers of younger adult patients	215
treated with the drug and control, the age distribution within the geriatric and younger adult	216
subpopulations, the specific safety or effectiveness outcomes of interest, the magnitudes of	217
differences in effects, and the variability in the outcomes. We recommend applicants contact the	218
Agency if they have questions about whether there is sufficient information to detect differences	219
in safety or effectiveness between geriatric and younger adult patients.	220
221
In general, integrated analyses of geriatric data from multiple studies can help increase the	222
precision of safety and effectiveness evaluations and provide a more clinically useful	223
representation of a drug’s benefit-risk profile in geriatric patients. Determination of whether and	224
how to include such integrated analyses in labeling should incorporate considerations about any	225
differences in design or conduct between studies. The method for integration should	226
appropriately account for the effect of differences in randomization ratios, patient populations,	227

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and other factors across studies and use statistically appropriate methods for integrating data	228
from multiple studies to minimize bias.31	
229
230
a. 	No observed differences in safety and/or effectiveness in geriatric patients	231
compared to younger adult patients (scenario 1.1)	232
233
If clinical studies included enough geriatric patients to make it likely that differences in safety or	234
effectiveness between geriatric and younger adult patients would have been detected, but no such	235
differences (in safety or effectiveness) were observed, and other reported clinical experience has	236
not identified such differences, the Geriatric Use subsection must contain the following	237
statement after information about the percentage (or number) of geriatric patients (see section	238
IV.A., Including Information in the Geriatric Use Subsection of Labeling (Scenarios 1.1, 1.2, and	239
1.3), of this gudiance):32	
240
241
“No overall differences in safety or effectiveness were observed between these subjects and	242
younger subjects, and other reported clinical experience has not identified differences in	243
responses between the elderly and younger patients, but greater sensitivity of some older	244
individuals cannot be ruled out.”	245
246
An alternative statement may be permitted, if the FDA determines that such statement is accurate	247
and appropriate.33 Permissible changes may include, but are not limited to, the following:	248
249
• 	Using the term patients instead of subjects	250
251
• 	Using the term younger adult patients instead of younger subjects if safety and	252
effectiveness comparisons were made between geriatric and younger adult patients (not	253
pediatric patients)	254
255
• 	Removing the phrase “other reported clinical experience has not identified differences in	256
responses between the elderly and younger patients” if there were no other clinical	257
experience in geriatric patients (beyond the clinical study data submitted to support drug	258
approval) because, for example, the drug is a new molecular entity that has never been	259
marketed in any country	260
261
• 	Removing the phrase “but greater sensitivity of some older individuals cannot be ruled	262
out” if this statement is inaccurate and/or clearly inapplicable for the drug34	
263
264
31 See the draft guidance for industry Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the
Safety of Human Drugs or Biological Products (November 2018). When final, this guidance will represent the
FDA’s current thinking on this topic.
32 21 CFR 201.57(c)(9)(v)(B)(2).
33 21 CFR 201.57(c)(9)(v)(F).
34 21 CFR 201.56(a)(2) and 21 CFR 201.56(d)(4).

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Such changes would result in an alternative statement such as the following:	265
266
“No overall differences in safety or effectiveness of DRUG X have been observed between	267
patients 65 years of age and older and younger adult patients.”	268
269
For most topical ophthalmic drugs there have been no observed differences in safety or	270
effectiveness between geriatric and younger adult patients in clinical studies. The systemic	271
absorption of topical ophthalmic drugs is usually minimal, and consequently, systemic effects are	272
unlikely and have been observed infrequently. Thus, when clinical differences between geriatric	273
and younger adult patients have not been demonstrated, applicants of topical ophthalmic drugs	274
may also use the alternative statement above.	275
276
b. 	Differences in safety and/or effectiveness in geriatric patients compared to	277
younger adult patients (scenario 1.2)	278
279
The Geriatric Use subsection must contain a summary of observed differences or specific	280
monitoring or dosage requirements in certain situations.35 These situations occur when clinical	281
studies and/or other reported clinical experience indicate that the use of the drug in geriatric	282
patients, compared to its use in younger adult patients, is associated with differences in safety or	283
effectiveness or requires specific monitoring or different recommended dosage in geriatric	284
patients. For example, if geriatric patients experienced unique adverse reactions, adverse	285
reactions occurred at a greater frequency or severity in geriatric patients than in younger adult	286
patients, or there was reduced effectiveness in geriatric patients, this information must appear in	287
the Geriatric Use subsection.36 As appropriate, this information must also be included in other	288
sections (e.g., DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, WARNINGS	289
AND PRECAUTIONS, ADVERSE REACTIONS, CLINICAL STUDIES).37 For example:	290
291
“The overall response rates in DRUG X-treated adult patients younger than 65 years of age,	292
65 years of age to younger than 75 years of age, and 75 years of age and older were 25%,	293
20%, and 15%, respectively. In comparison, the overall response rate for placebo-treated	294
patients in each of these subgroups was 10%.	295
296
In patients 65 years of age and older, consider premedication with drug 1, drug 2, and drug 3	297
before DRUG X use [see Dosage and Administration (2.x)]. In DRUG X-treated patients,	298
the incidence of ≥ Grade 3 gastrointestinal (GI) adverse reactions (i.e., nausea and vomiting)	299
was 10%, 35%, and 40% in adult patients younger than 65 years of age, 65 years of age to	300
younger than 75 years of age, and 75 years of age and older, respectively [see Adverse	301
Reactions (6.1)]. In comparison, in placebo-treated patients, ≥ Grade 3 GI adverse reactions	302
(i.e., nausea and vomiting) occurred in 1–3% of patients in the three subpopulations.”	303
304
35 See 21 CFR 201.57(c)(9)(v)(B)(3).
36 Ibid.
37 Ibid.

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2. 	When Information Is Insufficient to Detect Differences in Safety and/or	305
Effectiveness Between Geriatric and Younger Adult Patients — Geriatric Use	306
Subsection (Scenario 1.3)	307
308
If clinical studies did not include sufficient numbers of geriatric patients to determine whether	309
geriatric patients respond differently than younger adult patients, and other reported clinical	310
experience has not identified such differences, the Geriatric Use subsection must include the	311
following statement (with respect to format, the FDA recommends this statement appear after the	312
geriatric exposure information; see section IV.A., Including Information in the Geriatric Use	313
Subsection of Labeling (Scenarios 1.1, 1.2, and 1.3), in this guidance):38	
314
315
“Clinical studies of (name of drug) did not include sufficient numbers of subjects aged 65	316
and over to determine whether they respond differently from younger subjects. Other	317
reported clinical experience has not identified differences in responses between the elderly	318
and younger patients. In general, dose selection for an elderly patient should be cautious,	319
usually starting at the low end of the dosing range, reflecting the greater frequency of	320
decreased hepatic, renal, or cardiac function and of concomitant disease or other drug	321
therapy.”39	
322
323
An alternative statement may be permitted, if the FDA determines that such statement is accurate	324
and appropriate.40 In addition to the permissible changes noted for scenario 1.1, additional	325
changes may include, but are not limited to, the following:	326
327
• 	Defining the geriatric age group in the labeling	328
329
• 	Removing the following sentence if the drug has only one recommended starting dosage:	330
331
“In general, dose selection for an elderly patient should be cautious, usually starting at the	332
low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal,	333
or cardiac function and of concomitant disease or other drug therapy.”	334
335
Such changes would result in an alternative statement such as the following:	336
337
“Clinical studies of DRUG X did not include sufficient numbers of patients 65 years of age	338
and older to determine whether they respond differently from younger adult patients.”	339
340
When a drug is approved for adult patients (including geriatric patients) but there is limited or no	341
experience in geriatric patients because the disease/condition primarily occurs in pediatric	342
patients and/or younger adult patients (the disease/condition rarely occurs in geriatric patients)	343
38 21 CFR 201.57(c)(9)(v)(B)(1).
39 Ibid
40 21 CFR 201.57(c)(9)(v)(F).

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(e.g., Duchenne muscular dystrophy), the Geriatric Use subsection may contain the following or	344
another appropriate and accurate alternative statement:	345
346
“Disease A is largely a disease of pediatric and young adult patients. Clinical studies of	347
DRUG X did not include patients 65 years of age and older.”	348
349
If clinical studies primarily included geriatric patients and did not include sufficient numbers of	350
younger adult patients to determine whether geriatric patients respond differently than younger	351
adult patients, and there has been no other reported clinical experience in geriatric patients, we	352
recommend that the Geriatric Use subsection contain a statement clarifying why there is	353
insufficient information to detect differences in safety or effectiveness between geriatric and	354
younger adult patients. The following is an example of such a statement in this situation:	355
356
“Clinical studies of DRUG X did not include sufficient numbers of younger adult patients to	357
determine if patients 65 years of age and older respond differently than younger adult	358
patients.”	359
360
3. 	Additional Required and Recommended Information in the Geriatric Use Subsection	361
(Scenarios 1.1, 1.2, and 1.3)	362
363
a. 	Specific risks or safety concerns in geriatric patients — Geriatric Use	364
subsection (scenarios 1.1, 1.2, and 1.3)	365
366
The Geriatric Use subsection must also include specific risks or safety concerns (hazards)	367
associated with the use of the drug in geriatric patients and any need for specific monitoring, as	368
well as other information related to the safe and effective use of the drug in the geriatric	369
population.41 If appropriate, the hazard must be summarized in the BOXED WARNING,	370
CONTRAINDICATIONS, and/or WARNINGS AND PRECAUTIONS sections.42 The	371
following is an example of how to include information in the Geriatric Use subsection and cross-	372
reference other relevant sections for a drug associated with greater sedation and delirium in	373
geriatric patients compared to younger adult patients:	374
375
“Because DRUG X-treated geriatric patients (patients 65 years of age and older) had a higher	376
rate of sedation and delirium than control-treated geriatric patients (the rates were similar	377
between DRUG X-treated and control-treated younger adult patients), initiate DRUG X at a	378
lower dosage in geriatric patients [see Dosage and Administration (2.x) and Warnings and	379
Precautions (5.x)].”	380
381
41 21 CFR 201.57(c)(9)(v)(A), (B)(3), and (D).
42 21 CFR 201.57(c)(9)(v)(D) and 21 CFR 201.57(c)(1), (5), and (6).

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b. 	Summarizing specific pharmacokinetic or pharmacodynamic studies in	382
geriatric patients — Geriatric Use subsection (scenarios 1.1, 1.2, and 1.3)	383
384
If specific pharmacokinetic or pharmacodynamic studies have been carried out in geriatric	385
patients, they must be summarized in the Geriatric Use subsection and described in detail in the	386
CLINICAL PHARMACOLOGY section43 (the Geriatric Use subsection should include a cross-	387
reference to the CLINICAL PHARMACOLOGY section). For the fictitious drug DRUG X	388
(drugozide injection), examples of such statements in the Geriatric Use subsection include the	389
following:	390
391
• 	Example 1:	392
393
“Geriatric patients had higher plasma drugozide C max and AUC compared to younger	394
adult patients, and the plasma drugozide C max and AUC observed in geriatric patients	395
increases the risk of DRUG X-related adverse reactions [see Warnings and Precautions	396
(5.x) and Clinical Pharmacology (12.3)]. Therefore, the recommended dosage of DRUG	397
X in geriatric patients is lower than in younger adult patients [see Dosage and	398
Administration (2.x)].”44	
399
400
• 	Example 2:	401
402
“No clinically meaningful differences in the pharmacokinetics of drugozide were	403
observed in geriatric patients compared to younger adult patients [see Clinical	404
Pharmacology (12.3)].”	405
406
c. 	When a drug is known to be substantially excreted by the kidney —	407
Geriatric Use subsection (scenarios 1.1, 1.2, and 1.3)	408
409
If the drug is known to be substantially excreted by the kidney, the Geriatric Use subsection	410
must include the following statement:45	
411
412
“This drug is known to be substantially excreted by the kidney, and the risk of adverse	413
reactions to this drug may be greater in patients with impaired renal function. Because	414
elderly patients are more likely to have decreased renal function, care should be taken in dose	415
selection, and it may be useful to monitor renal function.”	416
417
An alternative statement may be permitted, if the FDA determines that such statement is accurate	418
and appropriate.46 Permissible changes may include, but are not limited to, the following:	419
420
43 21 CFR 201.57(c)(9)(v)(C)(1).
44 The term Cmax refers to maximum plasma concentration. The term AUC refers to area under the curve.
45 21 CFR 201.57(c)(9)(v)(C)(2).
46 21 CFR 201.57(c)(9)(v)(F).

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• 	Removing the phrase “risk of adverse reactions to this drug may be greater in patients	421
with impaired renal function” if the risk of adverse reactions is the same in patients with	422
renal impairment and in patients with normal renal function (e.g., the drug has a high	423
therapeutic index).	424
425
• 	Using the term geriatric patients rather than elderly patients.	426
427
• 	Removing the following phrase if the drug has only one recommended dosage or if the	428
labeling contains specific dosage recommendations for patients with renal impairment:	429
430
“Because elderly patients are more likely to have decreased renal function, care should be	431
taken in dose selection, and it may be useful to monitor renal function.”	432
433
• 	Removing the following phrase if the labeling includes specific recommendations for	434
monitoring renal function or if for the specific drug or disease/condition it would not be	435
useful to monitor for renal function:	436
437
“It may be useful to monitor renal function.”	438
439
Such changes would result in an alternative statement such as the following:	440
441
“DRUG X is substantially excreted by the kidney, and the risk of adverse reactions to DRUG	442
X may be greater in patients with renal impairment than in patients with normal renal	443
function. Because geriatric patients are more likely to have renal impairment, monitor for	444
Adverse Reactions Y and Z [see Warnings and Precautions (5.x) and Use in Specific	445
Populations (8.6)].”	446
447
Alternatively, this statement can be omitted if it is clearly inapplicable or misleading47 in the	448
Geriatric Use subsection (e.g., the drug is contraindicated or not recommended for use in	449
patients with moderate or severe renal impairment).48	
450
451
If the drug is known to be substantially excreted by the kidney, the Geriatric Use subsection	452
should, as appropriate, include a cross-reference to the Renal Impairment subsection (if any) in	453
the USE IN SPECIFIC POPULATIONS section,49 where clinically relevant details regarding use	454
in patients with renal impairment would be included.	455
456
47 See 21 CFR 201.56(a)(2) and 21 CFR 201.56(d)(4).
48 In this example, information about the risks of use of the drug in patients with renal impairment would be
described elsewhere in labeling (e.g., CONTRAINDICATIONS section, WARNINGS AND PRECAUTIONS
section, Renal Impairment subsection in the USE IN SPECIFIC POPULATIONS section).
49 See the draft guidance for industry Pharmacokinetics in Patients with Impaired Renal Function — Study Design,
Data Analysis, and Impact on Dosing and Labeling (March 2010). When final, this guidance will represent the
FDA’s current thinking on this topic.

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B. 	Including Geriatric Use Information in Other Sections of Labeling	457
(Scenarios 1.1, 1.2, and/or 1.3)	458
459
When the drug is approved for use generally in adult patients including geriatric patients (or a	460
subset of the geriatric population), information about geriatric use may be required in other	461
sections of the labeling. The following discusses both requirements and recommendations as to	462
placement of geriatric use information in the relevant sections of labeling. The required and	463
recommended information apply to scenarios 1.1, 1.2, and 1.3 unless otherwise noted.	464
465
• 	INDICATIONS AND USAGE: If a drug is indicated for use in the entire adult	466
population (including geriatric patients), then in general, the term adults should be	467
incorporated into the indication.50 For example:	468
469
“DRUG X is indicated for the treatment of Indication A in adults.”	470
471
• 	DOSAGE AND ADMINISTRATION: Typically, the recommended dosage in geriatric	472
patients is the same as the recommended dosage in younger adult patients. However, the	473
DOSAGE AND ADMINISTRATION section must include the recommended dosage in	474
geriatric patients if the recommended dosage in geriatric patients differs from the	475
recommended dosage in younger adult patients.51	
476
477
• 	WARNINGS AND PRECAUTIONS: Clinically significant adverse reactions or risks	478
that are unique to geriatric patients must be included in the WARNINGS AND	479
PRECAUTIONS section,52 and clinically significant adverse reactions or risks that occur	480
at a greater severity or frequency than in younger adult patients should generally also be	481
included in this section (generally applies to scenario 1.2).53	
482
483
• 	ADVERSE REACTIONS: If there are differences in the frequency, severity, or type of	484
adverse reactions in geriatric patients compared to younger adult patients or if there are	485
adverse reactions that are unique to geriatric patients, details of these adverse reaction	486
data should be included in the ADVERSE REACTIONS section (generally applies to	487
scenario 1.2).54 However, if there are no differences in frequency (e.g., no differences in	488
relative or absolute risk), severity, or type of adverse reactions in geriatric patients	489
50 See the draft guidance for industry Indications and Usage Section of Labeling for Human Prescription Drug and
Biological Products — Content and Format (July 2018). When final, this guidance will represent the FDA’s current
thinking on this topic.
51 See 21 CFR 201.57(c)(3)(C) and (H).
52 See 21 CFR 201.57(c)(9)(v)(D) and 21 CFR 201.57(c)(6).
53 See generally the guidance for industry Warnings and Precautions, Contraindications, and Boxed Warning
Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (October 2011).
54 See the guidance for industry Adverse Reactions Section of Labeling for Human Prescription Drug and Biological
Products — Content and Format (January 2006).

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compared to younger adult patients, it is not necessary to separately present adverse	490
reactions from geriatric patients in this section (generally applies to scenarios 1.1 and	491
1.3).	492
493
• 	CLINICAL PHARMACOLOGY: The CLINICAL PHARMACOLOGY section must	494
include detailed descriptions of pharmacokinetic and/or pharmacodynamic study data if	495
such studies were carried out in geriatric patients55 and should include relevant	496
pharmacogenomic study data, data obtained from population analyses, and dose response	497
information.56	
498
499
• 	CLINICAL STUDIES: Clinical studies that provide substantial evidence of	500
effectiveness for use of a drug in the geriatric population should be described in the	501
CLINICAL STUDIES section (e.g., study design(s), population(s), endpoint(s), results	502
and limitations of the study design or evidence).57	
503
504
505
V. 	DRUG IS APPROVED FOR A GERIATRIC-SPECIFIC INDICATION	506
(SCENARIO 2)	507
508
When a drug is approved for use for a geriatric-specific indication, the labeling must provide a	509
summary of information essential for safe and effective use in geriatric patients.58 The following	510
describes both requirements and recommendations regarding placement of geriatric use	511
information in relevant sections of labeling when a drug is approved for a geriatric-specific	512
indication:	513
514
• 	INDICATIONS AND USAGE: All geriatric indications supported by adequate and	515
well-controlled studies in geriatric patients must be included in the INDICATIONS AND	516
USAGE section.59 If the drug is indicated for use only in geriatric patients, in general,	517
the FDA recommends using the phrases “patients XX years of age and older,” “adults	518
XX years of age and older,” or similar phrases in the indication. For example:	519
520
“DRUG X is indicated for the treatment of Indication A in patients 65 years of age	521
and older.”	522
523
55 21 CFR 201.57(c)(9)(v)(C)(1) and 21 CFR 201.57(c)(13).
56 See the guidance for industry Clinical Pharmacology Section of Labeling for Human Prescription Drug and
Biological Products — Content and Format (December 2016).
57 See the guidance for industry Clinical Studies Section of Labeling for Human Prescription Drug and Biological
Products — Content and Format (January 2006).
58 21 CFR 201.56(a)(1).
59 21 CFR 201.57(c)(9)(v)(A).

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• 	DOSAGE AND ADMINISTRATION: This section must include the recommended	524
dosage in geriatric patients for all approved geriatric-specific indications.60	
525
526
• 	ADVERSE REACTIONS: Geriatric adverse reaction data must be included in the	527
ADVERSE REACTIONS section.61	
528
529
• 	USE IN SPECIFIC POPULATIONS, Geriatric Use subsection: Only a summary	530
statement of the approved geriatric indication(s) should be described in the Geriatric Use	531
subsection. For example:	532
533
“DRUG X is indicated in patients 65 years of age and older (for Indication A), and	534
the information on this use is discussed throughout the labeling.”	535
536
• 	CLINICAL PHARMACOLOGY: Data summarized in the Geriatric Use subsection	537
must be discussed in more detail, if appropriate, in the CLINICAL PHARMACOLOGY	538
section.62 Detailed descriptions of geriatric pharmacokinetic, pharmacodynamic, and/or	539
pharmacogenomic study data; relevant data obtained from population analyses; and dose	540
response information should be included in this section.63	
541
542
• 	CLINICAL STUDIES: Data summarized in the Geriatric Use subsection must be	543
discussed in more detail, if appropriate, in the CLINICAL STUDIES section.64 Detailed	544
descriptions of studies that provide substantial evidence of effectiveness for use in	545
geriatric patients (e.g., study design(s), population(s), endpoint(s), results and limitations	546
of the study design or evidence) should be provided in this section.65	
547
548
549
VI. 	DRUG IS NOT APPROVED IN THE GERIATRIC POPULATION	550
551
Drugs that are studied only in younger adult patients (not geriatric patients) are typically	552
approved for all adult patients (including geriatric patients) because of generalizability of the	553
evidence to geriatric patients, consistencies in the disease processes across geriatric and younger	554
adults, and the drug’s overall benefits and risks. However, there are uncommon situations when	555
the evidence does not support the use of a drug in a geriatric population because clinical studies	556
60 21 CFR 201.57(c)(3)(C) and 21 CFR 201.57(c)(9)(v)(A).
61 21 CFR 201.57(c)(7).
62 21 CFR 201.57(c)(9)(v)(A) and 21 CFR 201.57(c)(9)(v)(C)(1).
63 See the guidance for industry Clinical Pharmacology Section of Labeling for Human Prescription Drug and
Biological Products — Content and Format. See also 21 CFR 201.57(c)(13).
64 21 CFR 201.57(c)(9)(v)(A).
65 See the guidance for industry Clinical Studies Section of Labeling for Human Prescription Drug and Biological
Products — Content and Format. See also 21 CFR 201.57(c)(15).

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did not include a sufficient number of geriatric patients to support geriatric use for an	557
indication.66 Additionally, there are uncommon situations when the evidence does not support	558
the use of a drug in a geriatric population because the results of studies conducted in a geriatric	559
population strongly suggest that the drug is ineffective or the benefit-risk profile is unfavorable	560
(but the evidence falls short of warranting a contraindication).67	
561
562
We recommend applicants contact the Agency if they have questions about developing labeling	563
for these uncommon situations.	564
565
If the use of the drug in geriatric patients is associated with a risk or safety concern (hazard) in	566
geriatric patients, the risk or safety concern must be described in the Geriatric Use subsection or,	567
if appropriate, must be stated in the CONTRAINDICATIONS and/or WARNINGS AND	568
PRECAUTIONS section(s), and the Geriatric Use subsection must cross-reference the section or	569
sections, if appropriate.68 Any such hazard must be stated in other sections of labeling (e.g.,	570
BOXED WARNING), as appropriate.69	
571
572
573
VII. 	OMITTING OR REVISING INFORMATION AND UPDATING LABELING	574
575
If an applicant believes that none of the requirements described in 21 CFR 201.57(c)(9)(v)(A) to	576
(E) is appropriate or relevant to its drug’s labeling, the applicant must provide a rationale for	577
omission of the statement(s) and may propose an alternative statement.70 The FDA may permit	578
omission of such statement(s) or alternative appropriate and accurate statement(s) if the FDA	579
determines that no statement(s) described in 21 CFR 201.57(c)(9)(v)(A) to (E) are appropriate or	580
relevant to the drug’s labeling.71 In some circumstances, applicants should omit specific	581
information otherwise required in the Geriatric Use subsection or omit the entire subsection	582
because the information is clearly inapplicable; applicants must omit such specific information or	583
66 These situations are different from situations when the entire Geriatric Use subsection is omitted because the
information is clearly inapplicable or misleading (see section VII., Omitting or Revising Information and Updating
Labeling).
67 Ibid.
68 21 CFR 201.57(c)(9)(v)(D).
69 The BOXED WARNING section requires that certain contraindications or serious warnings may be required by
the FDA to be presented in a box (21 CFR 201.57(c)(1)). The WARNINGS AND PRECAUTIONS “section must
describe clinically significant adverse reactions (including any that are potentially fatal, are serious even if
infrequent, or can be prevented or mitigated through appropriate use of the drug), other potential safety hazards” (21
CFR 201.57(c)(6)(i)). The CONTRAINDICATIONS “section must describe any situations in which the drug
should not be used because the risk of use (e.g., certain potentially fatal adverse reactions) clearly outweighs any
possible therapeutic benefit … Known hazards and not theoretical possibilities must be listed” (21 CFR
201.57(c)(5)).
70 21 CFR 201.57(c)(9)(v)(F).
71 Ibid.

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the entire subsection if it is misleading.72 For example, if a drug is indicated for use only in	584
neonates, the applicant should omit the Geriatric Use subsection because this subsection is	585
clearly inapplicable. We recommend applicants contact the Agency if they have questions about	586
omitting certain regulatory statements in the Geriatric Use subsection.	587
588
Labeling must be updated when new information becomes available that causes the labeling to	589
become inaccurate, false, or misleading.73 Consistent with this requirement, when revising	590
existing information in the labeling, applicants should evaluate labeling content to ensure that it	591
accurately reflects current knowledge about the use of the drug in geriatric patients for all	592
approved indications. Applicants should evaluate available results from postmarketing	593
controlled clinical studies, well-documented studies obtained from a literature search that are	594
available to the applicant and reasonably relevant to the use of the drug in geriatric patients,	595
pharmacokinetic and pharmacodynamic studies conducted in geriatric patients, and adverse	596
event reports.74 Applicants should review and update sections of labeling pertinent to the	597
geriatric use information as necessary when updating the labeling.	598
72 Under 21 CFR 201.56(a)(2), “labeling must be informative and accurate and neither promotional in tone nor false
or misleading.” Under 21 CFR 201.56(d)(4), “[o]mit clearly inapplicable sections, subsections, or specific
information.” For additional information on omitting information in labeling, see the guidance for industry Labeling
for Human Prescription Drug and Biological Products — Implementing the PLR Content and Format Requirements
(February 2013).
73 21 CFR 201.56(a)(2).
74 See 21 CFR 201.57(c)(9)(v)(B), which requires that such information be reflected in the Geriatric Use subsection.