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DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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 
 
33150061dft.docx 
9/8/2020   
Geriatric Information in 
Human Prescription Drug 
and Biological Product 
Labeling 
Guidance for Industry  
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
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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Draft  Not for Implementation 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 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Geriatric Information in Human Prescription  
2  Drug and Biological Product Labeling 
3  Guidance for Industry1 
4   
5   
6   
7  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
8  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
9  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
10  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
11  for this guidance as listed on the title page. 
12   
13   
14   
15  I.  INTRODUCTION 
16   
17  This guidance is intended to assist applicants of human prescription drug and biological 
18  products2 in determining the appropriate placement and content of geriatric information in 
19  labeling as described in the regulations for the content and format of labeling for human 
20  prescription drug and biological products.3,4 
21   
22  The goal of this guidance is to provide recommendations to help ensure that appropriate 
23  information on the use of prescription drugs in geriatric patients is consistently placed in the 
24  proper sections and subsections within labeling so that the information is clear and accessible to 
25  health care practitioners and includes content that guides the safe and effective use in geriatric 
26  patients.   
27   
28  This guidance, which replaces the withdrawn guidance for industry Content and Format for 
29  Geriatric Labeling (October 2001), provides additional examples of geriatric use statements in 
30  labeling and examples of when the labeling regulations authorize the FDA to permit applicants to 
31  omit or revise specific information otherwise required in the Geriatric Use subsection. 
32   
33  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
34  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
35  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
                                                 
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.   
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
36  the word should in Agency guidances means that something is suggested or recommended, but 
37  not required. 
38   
39   
40  II.  BACKGROUND 
41   
42  A.  Geriatric Initiatives 
43   
44  1.  Geriatric Clinical Data Initiatives 
45   
46  In the 1980s, the FDA began several initiatives to increase the quantity and quality of 
47  information about the use of drugs in geriatric patients (defined as patients 65 years of age and 
48  older) so that health care practitioners would have enough information for the safe and effective 
49  use of drugs in geriatric patients.  For example, the FDA encourages a thorough evaluation of the 
50  effectiveness and safety of drugs in geriatric patients and recommends examination of age-
51  related differences in effectiveness, dose response, and safety.5  In 1998, the FDA required new 
52  drug application (NDA) holders6 and, subsequently, recommended that biologics license 
53  application (BLA) holders7 present in their applications effectiveness and safety data based on 
54  age.  In 2012, in an International Conference on Harmonisation (ICH) guidance for industry, the 
55  FDA reaffirmed the importance of obtaining geriatric data, across the entire full age range of the 
56  geriatric population because of the likelihood of comorbidities and the increasing number of 
57  geriatric patients in the United States.8  The guidance also noted ways in which geriatric patients 
58  (especially patients 75 years of age and older) may respond differently to drug therapy than 
59  younger adult patients.9   
60   
61  In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) directed the 
62  FDA to report on the inclusion of demographic subgroups (including age subgroups) in clinical 
                                                 
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. 
 
 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
63  studies and the analysis of these demographic subgroups (including age subgroups) in NDAs and 
64  BLAs.10   
65   
66  2.  Geriatric Labeling Initiatives 
67   
68  Until the late 1990s, the majority of drug labeling contained minimal or no geriatric use 
69  information to guide safe and effective use in the geriatric population.  In 1997, the FDA issued a 
70  final rule creating a Geriatric Use subsection of labeling to promote the consistent inclusion of 
71  all relevant geriatric information in labeling.11  This subsection is intended to provide 
72  information on possible differences in the safety, effectiveness, pharmacodynamics, and/or 
73  pharmacokinetics between geriatric and younger adult patients given differences in responses, 
74  drug elimination, comorbidities, organ function (e.g., renal function), consequences of adverse 
75  reactions, and concomitant therapy (e.g., higher risk of drug interactions because of 
76  polypharmacy).   
77   
78  In 2001, the FDA issued the now-withdrawn guidance for industry Content and Format for 
79  Geriatric Labeling, which provided recommendations for the Geriatric Use subsection in the 
80  PRECAUTIONS section.  In 2006, the FDA issued the final rule Requirements on Content and 
81  Format of Labeling for Human Prescription Drug and Biological Products (commonly referred 
82  to as the physician labeling rule (PLR)), which relocated the Geriatric Use subsection from the 
83  PRECAUTIONS section in old (non-PLR) format labeling to the USE IN SPECIFIC 
84  POPULATIONS section for labeling required to be in PLR format.12   
85   
86  B.  Geriatric Population in Labeling 
87   
88  In general, for prescription drug labeling, the adult population is defined as patients 17 years of 
89  age and older, and the geriatric population is defined as patients 65 years of age and older.13  
90  Therefore, information in labeling that is pertinent to the adult population is typically also 
91  pertinent to the geriatric population (e.g., indications approved in adults include geriatric 
92  patients).14   
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 FDAs current 
thinking on this topic.   
 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
94  The information in the Geriatric Use subsection must pertain to the use of the drug in patients 65 
95  years of age and older, unless otherwise noted.15  Patients 65 years of age and older are not a 
96  homogeneous group (e.g., differences in organ function, comorbidities, concomitant drugs, and 
97  drug distribution and elimination).  Applicants should include information on additional geriatric 
98  age subgroups in the labeling if important differences exist in responses in these subgroups.16  
99  Such subgroups should be further defined in the labeling as appropriate (e.g., 65-74 years of age; 
100  75-84 years of age; and 85 years of age and older).17  In some cases, geriatric age might be 
101  expressed as a continuous function of age.18   
102   
103   
104  III.  OVERVIEW OF GERIATRIC USE INFORMATION IN HUMAN 
105  PRESCRIPTION DRUG AND BIOLOGICAL PRODUCT LABELING 
106   
107  In general, applicants must summarize certain geriatric use information in the Geriatric Use 
108  subsection19 and, when appropriate, must cross-reference the appropriate section(s) or 
109  subsection(s) of labeling that provide more detailed geriatric use information.20  Certain geriatric 
110  use information must be included based on the type of information being conveyed,21 which can 
111  be characterized as follows: 
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., 6574 years of age, 7584 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 drugs 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). 
 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
113   
114    Three scenarios (i.e., scenarios 1.1, 1.2, and 1.3) in which the drug is approved for use in 
115  adult patients generally, including geriatric patients or a subset of the geriatric 
116  population: 
117   
118    Scenario 1.1:  When information is sufficient to detect differences in safety and/or 
119  effectiveness between geriatric and younger adult patients and there were no observed 
120  differences in safety and/or effectiveness between these groups22  
121   
122    Scenario 1.2:  When information is sufficient to detect differences in safety and/or 
123  effectiveness between geriatric and younger adult patients and differences in safety 
124  and/or effectiveness between these groups were observed23 
125   
126    Scenario 1.3:  When information is insufficient to detect differences in safety and/or 
127  effectiveness between geriatric and younger adult patients24 
128   
129    Scenario 2 in which the drug is approved for a geriatric-specific indication25 (i.e., for a 
130  specific indication, the drug is indicated for use only in geriatric patients (or a subset of 
131  the geriatric population) and not in adult patients less than 65 years old). 
132   
133  The following sections provide more detailed descriptions of scenarios 1.1, 1.2, 1.3, and 2 and 
134  geriatric information that is required or recommended for inclusion in relevant sections and 
135  subsections of labeling. 
136   
137   
138  IV.  DRUG IS APPROVED FOR USE GENERALLY IN ADULT PATIENTS 
139  INCLUDING GERIATRIC PATIENTS OR A SUBSET OF THE GERIATRIC 
140  POPULATION (SCENARIOS 1.1, 1.2, AND 1.3) 
141   
142  A.  Including Information in the Geriatric Use Subsection of Labeling (Scenarios 
143  1.1, 1.2, and 1.3) 
144   
145  The Geriatric Use subsection must include certain information pertinent to the safe and effective 
146  use of the drug in geriatric patients for all indications approved for use in adult patients 
147  (including geriatric patients).26 
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). 
 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
149  Information in this subsection is typically derived from results from controlled clinical studies 
150  submitted in the application or supplement(s) that are relevant to the use of the drug in geriatric 
151  patients.  However, sometimes information in this subsection is obtained from other reported 
152  clinical experience27 such as, but not limited to, well-documented studies obtained from a 
153  literature search, clinically relevant information from registries, other epidemiological or 
154  surveillance studies, case series studies, and adverse event reports.28 
155   
156  Under scenario 1.1, the Geriatric Use subsection must include the percentage of patients 65 
157  years of age and older and the percentage of patients 75 years of age and older (or the total 
158  number of patients 65 years of age and older and the total number of patients 75 years of age and 
159  older) in the clinical studies of the drug.29  Under this scenario, to provide more information to 
160  health care practitioners about geriatric exposure, the FDA recommends that this subsection 
161  present both the number and percentage of drug-exposed patients 65 years of age and older, and 
162  the number and percentage of drug-exposed patients 75 years of age and older in a defined group 
163  of clinical studies (typically the clinical studies that supported the approval of the drug in adult 
164  patients, including geriatric patients).  Under scenario 1.1, alternative age cutoff point(s) within 
165  the geriatric population may be permitted to describe drug exposure, if the FDA determines that 
166  such age cutoff point(s) are accurate and appropriate.30   
167   
168  Under scenarios 1.2 and 1.3, the FDA recommends including geriatric exposure information in 
169  the Geriatric Use subsection.  Specifically, we recommend that this subsection provide both the 
170  number and percentage of drug-exposed geriatric patients in a defined group of clinical studies 
171  (typically the clinical studies that supported the approval of the drug in adult patients, including 
172  geriatric patients).  Different age cutoff points within the geriatric population can be selected to 
173  describe drug exposure, depending on the database (see section II.B., Geriatric Population in 
174  Labeling, in this guidance). 
175   
176  Under scenarios 1.1, 1.2, and 1.3, the Geriatric Use subsection can also include information on 
177  the total number of geriatric patients in the clinical studies (e.g., including drug-treated patients 
178  and control-treated patients).  Under these scenarios, we recommend that this subsection cross-
179  reference to other sections of labeling that contain additional details about the studies used to 
180  determine the geriatric exposure (e.g., the CLINICAL STUDIES section).   
181   
182  In general, geriatric exposure information should be placed at the beginning of the Geriatric Use 
183  subsection.  However, information on specific risks or safety concerns associated with the use of 
184  the drug in geriatric patients and/or recommendations on specific monitoring in geriatric patients 
185  may appear before the drug exposure information.   
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). 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
187  The following examples represent options for summarizing geriatric exposure information under 
188  scenarios 1.1, 1.2, and/or 1.3; alternative language can be proposed. 
189   
190    Example 1: 
191   
192  There were n patients 65 years of age and older in the clinical studies for Disease A [see 
193  Clinical Studies (14)].  Of the total number of DRUG X-treated patients in these studies, 
194  n (y%) were 65 years of age and older, while n (z%) were 75 years of age and older.   
195   
196    Example 2: 
197   
198  Of the total number of DRUG X-treated patients in clinical studies for Disease A, n 
199  (y%) were 65 to 74 years of age, and n (z%) were 75 years of age and older [see Clinical 
200  Studies (14)].  
201   
202    Example 3: 
203   
204  There were n patients 65 years of age and older in the clinical studies for Disease A, 
205  Disease B, and Disease C [see Clinical Studies (14.1, 14.2, 14.3)].  Of the total number 
206  of DRUG X-treated patients in these studies, n (x%) were 65 to 74 years of age, n (y%) 
207  were 75 to 84 years of age, and n (z%) were 85 years of age and older.     
208   
209  1.  When Information Is Sufficient to Detect Differences in Safety and/or 
210  Effectiveness Between Geriatric and Younger Adult Patients  Geriatric Use 
211  Subsection (Scenarios 1.1 and 1.2) 
212   
213  Factors that can affect whether there is sufficient information to detect differences in safety or 
214  effectiveness between geriatric and younger adult patients include the numbers of geriatric 
215  patients treated with the drug and control compared with the numbers of younger adult patients 
216  treated with the drug and control, the age distribution within the geriatric and younger adult 
217  subpopulations, the specific safety or effectiveness outcomes of interest, the magnitudes of 
218  differences in effects, and the variability in the outcomes.  We recommend applicants contact the 
219  Agency if they have questions about whether there is sufficient information to detect differences 
220  in safety or effectiveness between geriatric and younger adult patients. 
221   
222  In general, integrated analyses of geriatric data from multiple studies can help increase the 
223  precision of safety and effectiveness evaluations and provide a more clinically useful 
224  representation of a drugs benefit-risk profile in geriatric patients.  Determination of whether and 
225  how to include such integrated analyses in labeling should incorporate considerations about any 
226  differences in design or conduct between studies.  The method for integration should 
227  appropriately account for the effect of differences in randomization ratios, patient populations, 
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Draft  Not for Implementation 
228  and other factors across studies and use statistically appropriate methods for integrating data 
229  from multiple studies to minimize bias.31 
230   
231  a.  No observed differences in safety and/or effectiveness in geriatric patients 
232  compared to younger adult patients (scenario 1.1) 
233   
234  If clinical studies included enough geriatric patients to make it likely that differences in safety or 
235  effectiveness between geriatric and younger adult patients would have been detected, but no such 
236  differences (in safety or effectiveness) were observed, and other reported clinical experience has 
237  not identified such differences, the Geriatric Use subsection must contain the following 
238  statement after information about the percentage (or number) of geriatric patients (see section 
239  IV.A., Including Information in the Geriatric Use Subsection of Labeling (Scenarios 1.1, 1.2, and 
240  1.3), of this gudiance):32  
241   
242  No overall differences in safety or effectiveness were observed between these subjects and 
243  younger subjects, and other reported clinical experience has not identified differences in 
244  responses between the elderly and younger patients, but greater sensitivity of some older 
245  individuals cannot be ruled out. 
246   
247  An alternative statement may be permitted, if the FDA determines that such statement is accurate 
248  and appropriate.33  Permissible changes may include, but are not limited to, the following: 
249   
250    Using the term patients instead of subjects 
251   
252    Using the term younger adult patients instead of younger subjects if safety and 
253  effectiveness comparisons were made between geriatric and younger adult patients (not 
254  pediatric patients) 
255   
256    Removing the phrase other reported clinical experience has not identified differences in 
257  responses between the elderly and younger patients if there were no other clinical 
258  experience in geriatric patients (beyond the clinical study data submitted to support drug 
259  approval) because, for example, the drug is a new molecular entity that has never been 
260  marketed in any country 
261   
262    Removing the phrase but greater sensitivity of some older individuals cannot be ruled 
263  out if this statement is inaccurate and/or clearly inapplicable for the drug34 
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 
FDAs 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). 
 
  8  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
265  Such changes would result in an alternative statement such as the following: 
266   
267  No overall differences in safety or effectiveness of DRUG X have been observed between 
268  patients 65 years of age and older and younger adult patients. 
269   
270  For most topical ophthalmic drugs there have been no observed differences in safety or 
271  effectiveness between geriatric and younger adult patients in clinical studies.  The systemic 
272  absorption of topical ophthalmic drugs is usually minimal, and consequently, systemic effects are 
273  unlikely and have been observed infrequently.  Thus, when clinical differences between geriatric 
274  and younger adult patients have not been demonstrated, applicants of topical ophthalmic drugs 
275  may also use the alternative statement above. 
276   
277  b.  Differences in safety and/or effectiveness in geriatric patients compared to 
278  younger adult patients (scenario 1.2) 
279   
280  The Geriatric Use subsection must contain a summary of observed differences or specific 
281  monitoring or dosage requirements in certain situations.35  These situations occur when clinical 
282  studies and/or other reported clinical experience indicate that the use of the drug in geriatric 
283  patients, compared to its use in younger adult patients, is associated with differences in safety or 
284  effectiveness or requires specific monitoring or different recommended dosage in geriatric 
285  patients.  For example, if geriatric patients experienced unique adverse reactions, adverse 
286  reactions occurred at a greater frequency or severity in geriatric patients than in younger adult 
287  patients, or there was reduced effectiveness in geriatric patients, this information must appear in 
288  the Geriatric Use subsection.36  As appropriate, this information must also be included in other 
289  sections (e.g., DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, WARNINGS 
290  AND PRECAUTIONS, ADVERSE REACTIONS, CLINICAL STUDIES).37  For example: 
291   
292  The overall response rates in DRUG X-treated adult patients younger than 65 years of age, 
293  65 years of age to younger than 75 years of age, and 75 years of age and older were 25%, 
294  20%, and 15%, respectively.  In comparison, the overall response rate for placebo-treated 
295  patients in each of these subgroups was 10%.   
296   
297  In patients 65 years of age and older, consider premedication with drug 1, drug 2, and drug 3 
298  before DRUG X use [see Dosage and Administration (2.x)].  In DRUG X-treated patients, 
299  the incidence of  Grade 3 gastrointestinal (GI) adverse reactions (i.e., nausea and vomiting) 
300  was 10%, 35%, and 40% in adult patients younger than 65 years of age, 65 years of age to 
301  younger than 75 years of age, and 75 years of age and older, respectively [see Adverse 
302  Reactions (6.1)].  In comparison, in placebo-treated patients,  Grade 3 GI adverse reactions 
303  (i.e., nausea and vomiting) occurred in 13% of patients in the three subpopulations.   
304   
                                                 
35 See 21 CFR 201.57(c)(9)(v)(B)(3). 
 
36 Ibid. 
 
37 Ibid. 
 
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305  2.  When Information Is Insufficient to Detect Differences in Safety and/or 
306  Effectiveness Between Geriatric and Younger Adult Patients  Geriatric Use 
307  Subsection (Scenario 1.3) 
308   
309  If clinical studies did not include sufficient numbers of geriatric patients to determine whether 
310  geriatric patients respond differently than younger adult patients, and other reported clinical 
311  experience has not identified such differences, the Geriatric Use subsection must include the 
312  following statement (with respect to format, the FDA recommends this statement appear after the 
313  geriatric exposure information; see section IV.A., Including Information in the Geriatric Use 
314  Subsection of Labeling (Scenarios 1.1, 1.2, and 1.3), in this guidance):38 
315   
316  Clinical studies of (name of drug) did not include sufficient numbers of subjects aged 65 
317  and over to determine whether they respond differently from younger subjects.  Other 
318  reported clinical experience has not identified differences in responses between the elderly 
319  and younger patients.  In general, dose selection for an elderly patient should be cautious, 
320  usually starting at the low end of the dosing range, reflecting the greater frequency of 
321  decreased hepatic, renal, or cardiac function and of concomitant disease or other drug 
322  therapy.39 
323   
324  An alternative statement may be permitted, if the FDA determines that such statement is accurate 
325  and appropriate.40  In addition to the permissible changes noted for scenario 1.1, additional 
326  changes may include, but are not limited to, the following: 
327   
328    Defining the geriatric age group in the labeling  
329   
330    Removing the following sentence if the drug has only one recommended starting dosage:   
331   
332  In general, dose selection for an elderly patient should be cautious, usually starting at the 
333  low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, 
334  or cardiac function and of concomitant disease or other drug therapy. 
335   
336  Such changes would result in an alternative statement such as the following: 
337   
338  Clinical studies of DRUG X did not include sufficient numbers of patients 65 years of age 
339  and older to determine whether they respond differently from younger adult patients.   
340   
341  When a drug is approved for adult patients (including geriatric patients) but there is limited or no 
342  experience in geriatric patients because the disease/condition primarily occurs in pediatric 
343  patients and/or younger adult patients (the disease/condition rarely occurs in geriatric patients) 
                                                 
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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344  (e.g., Duchenne muscular dystrophy), the Geriatric Use subsection may  contain the following or 
345  another appropriate and accurate alternative statement: 
346   
347  Disease A is largely a disease of pediatric and young adult patients.  Clinical studies of 
348  DRUG X did not include patients 65 years of age and older. 
349   
350  If clinical studies primarily included geriatric patients and did not include sufficient numbers of 
351  younger adult patients to determine whether geriatric patients respond differently than younger 
352  adult patients, and there has been no other reported clinical experience in geriatric patients, we 
353  recommend that the Geriatric Use subsection contain a statement clarifying why there is 
354  insufficient information to detect differences in safety or effectiveness between geriatric and 
355  younger adult patients.  The following is an example of such a statement in this situation:   
356   
357  Clinical studies of DRUG X did not include sufficient numbers of younger adult patients to 
358  determine if patients 65 years of age and older respond differently than younger adult 
359  patients. 
360   
361  3.  Additional Required and Recommended Information in the Geriatric Use Subsection 
362  (Scenarios 1.1, 1.2, and 1.3) 
363   
364  a.  Specific risks or safety concerns in geriatric patients  Geriatric Use 
365  subsection (scenarios 1.1, 1.2, and 1.3) 
366   
367  The Geriatric Use subsection must also include specific risks or safety concerns (hazards) 
368  associated with the use of the drug in geriatric patients and any need for specific monitoring, as 
369  well as other information related to the safe and effective use of the drug in the geriatric 
370  population.41  If appropriate, the hazard must be summarized in the BOXED WARNING, 
371  CONTRAINDICATIONS, and/or WARNINGS AND PRECAUTIONS sections.42  The 
372  following is an example of how to include information in the Geriatric Use subsection and cross-
373  reference other relevant sections for a drug associated with greater sedation and delirium in 
374  geriatric patients compared to younger adult patients: 
375   
376  Because DRUG X-treated geriatric patients (patients 65 years of age and older) had a higher 
377  rate of sedation and delirium than control-treated geriatric patients (the rates were similar 
378  between DRUG X-treated and control-treated younger adult patients), initiate DRUG X at a 
379  lower dosage in geriatric patients [see Dosage and Administration (2.x) and Warnings and 
380  Precautions (5.x)].  
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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382  b.  Summarizing specific pharmacokinetic or pharmacodynamic studies in 
383  geriatric patients  Geriatric Use subsection (scenarios 1.1, 1.2, and 1.3) 
384   
385  If specific pharmacokinetic or pharmacodynamic studies have been carried out in geriatric 
386  patients, they must be summarized in the Geriatric Use subsection and described in detail in the 
387  CLINICAL PHARMACOLOGY section43 (the Geriatric Use subsection should include a cross-
388  reference to the CLINICAL PHARMACOLOGY section).  For the fictitious drug DRUG X 
389  (drugozide injection), examples of such statements in the Geriatric Use subsection include the 
390  following:   
391   
392    Example 1: 
393   
394  Geriatric patients had higher plasma drugozide C  and AUC compared to younger 
max
395  adult patients, and the plasma drugozide C  and AUC observed in geriatric patients 
max
396  increases the risk of DRUG X-related adverse reactions [see Warnings and Precautions 
397  (5.x) and Clinical Pharmacology (12.3)].  Therefore, the recommended dosage of DRUG 
398  X in geriatric patients is lower than in younger adult patients [see Dosage and 
399  Administration (2.x)].44 
400   
401    Example 2: 
402   
403  No clinically meaningful differences in the pharmacokinetics of drugozide were 
404  observed in geriatric patients compared to younger adult patients [see Clinical 
405  Pharmacology (12.3)]. 
406   
407  c.  When a drug is known to be substantially excreted by the kidney  
408  Geriatric Use subsection (scenarios 1.1, 1.2, and 1.3) 
409   
410  If the drug is known to be substantially excreted by the kidney, the Geriatric Use subsection 
411  must include the following statement:45  
412   
413  This drug is known to be substantially excreted by the kidney, and the risk of adverse 
414  reactions to this drug may be greater in patients with impaired renal function.  Because 
415  elderly patients are more likely to have decreased renal function, care should be taken in dose 
416  selection, and it may be useful to monitor renal function. 
417   
418  An alternative statement may be permitted, if the FDA determines that such statement is accurate 
419  and appropriate.46  Permissible changes may include, but are not limited to, the following: 
420   
                                                 
43 21 CFR 201.57(c)(9)(v)(C)(1). 
 
44 The term C  refers to maximum plasma concentration. The term AUC refers to area under the curve. 
max
 
45 21 CFR 201.57(c)(9)(v)(C)(2). 
 
46 21 CFR 201.57(c)(9)(v)(F). 
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421    Removing the phrase risk of adverse reactions to this drug may be greater in patients 
422  with impaired renal function if the risk of adverse reactions is the same in patients with 
423  renal impairment and in patients with normal renal function (e.g., the drug has a high 
424  therapeutic index).  
425   
426    Using the term geriatric patients rather than elderly patients. 
427   
428    Removing the following phrase if the drug has only one recommended dosage or if the 
429  labeling contains specific dosage recommendations for patients with renal impairment:   
430   
431  Because elderly patients are more likely to have decreased renal function, care should be 
432  taken in dose selection, and it may be useful to monitor renal function. 
433   
434    Removing the following phrase if the labeling includes specific recommendations for 
435  monitoring renal function or if for the specific drug or disease/condition it would not be 
436  useful to monitor for renal function:   
437   
438  It may be useful to monitor renal function. 
439   
440  Such changes would result in an alternative statement such as the following: 
441   
442  DRUG X is substantially excreted by the kidney, and the risk of adverse reactions to DRUG 
443  X may be greater in patients with renal impairment than in patients with normal renal 
444  function.  Because geriatric patients are more likely to have renal impairment, monitor for 
445  Adverse Reactions Y and Z [see Warnings and Precautions (5.x) and Use in Specific 
446  Populations (8.6)]. 
447   
448  Alternatively, this statement can be omitted if it is clearly inapplicable or misleading47 in the 
449  Geriatric Use subsection (e.g., the drug is contraindicated or not recommended for use in 
450  patients with moderate or severe renal impairment).48   
451   
452  If the drug is known to be substantially excreted by the kidney, the Geriatric Use subsection 
453  should, as appropriate, include a cross-reference to the Renal Impairment subsection (if any) in 
454  the USE IN SPECIFIC POPULATIONS section,49 where clinically relevant details regarding use 
455  in patients with renal impairment would be included. 
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 
FDAs current thinking on this topic. 
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457  B.  Including Geriatric Use Information in Other Sections of Labeling 
458  (Scenarios 1.1, 1.2, and/or 1.3) 
459   
460  When the drug is approved for use generally in adult patients including geriatric patients (or a 
461  subset of the geriatric population), information about geriatric use may be required in other 
462  sections of the labeling.  The following discusses both requirements and recommendations as to 
463  placement of geriatric use information in the relevant sections of labeling.  The required and 
464  recommended information apply to scenarios 1.1, 1.2, and 1.3 unless otherwise noted. 
465   
466    INDICATIONS AND USAGE:  If a drug is indicated for use in the entire adult 
467  population (including geriatric patients), then in general, the term adults should be 
468  incorporated into the indication.50  For example: 
469   
470  DRUG X is indicated for the treatment of Indication A in adults. 
471   
472    DOSAGE AND ADMINISTRATION:  Typically, the recommended dosage in geriatric 
473  patients is the same as the recommended dosage in younger adult patients.  However, the 
474  DOSAGE AND ADMINISTRATION section must include the recommended dosage in 
475  geriatric patients if the recommended dosage in geriatric patients differs from the 
476  recommended dosage in younger adult patients.51     
477   
478    WARNINGS AND PRECAUTIONS:  Clinically significant adverse reactions or risks 
479  that are unique to geriatric patients must be included in the WARNINGS AND 
480  PRECAUTIONS section,52 and clinically significant adverse reactions or risks that occur 
481  at a greater severity or frequency than in younger adult patients should generally also be 
482  included in this section (generally applies to scenario 1.2).53 
483   
484    ADVERSE REACTIONS:  If there are differences in the frequency, severity, or type of 
485  adverse reactions in geriatric patients compared to younger adult patients or if there are 
486  adverse reactions that are unique to geriatric patients, details of these adverse reaction 
487  data should be included in the ADVERSE REACTIONS section (generally applies to 
488  scenario 1.2).54  However, if there are no differences in frequency (e.g., no differences in 
489  relative or absolute risk), severity, or type of adverse reactions in geriatric patients 
                                                 
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 FDAs 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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490  compared to younger adult patients, it is not necessary to separately present adverse 
491  reactions from geriatric patients in this section (generally applies to scenarios 1.1 and 
492  1.3).   
493   
494    CLINICAL PHARMACOLOGY:  The CLINICAL PHARMACOLOGY section must 
495  include detailed descriptions of pharmacokinetic and/or pharmacodynamic study data if 
496  such studies were carried out in geriatric patients55 and should include relevant 
497  pharmacogenomic study data, data obtained from population analyses, and dose response 
498  information.56   
499   
500    CLINICAL STUDIES:  Clinical studies that provide substantial evidence of 
501  effectiveness for use of a drug in the geriatric population should be described in the 
502  CLINICAL STUDIES section (e.g., study design(s), population(s), endpoint(s), results 
503  and limitations of the study design or evidence).57 
504   
505   
506  V.  DRUG IS APPROVED FOR A GERIATRIC-SPECIFIC INDICATION 
507  (SCENARIO 2) 
508   
509  When a drug is approved for use for a geriatric-specific indication, the labeling must provide a 
510  summary of information essential for safe and effective use in geriatric patients.58  The following 
511  describes both requirements and recommendations regarding placement of geriatric use 
512  information in relevant sections of labeling when a drug is approved for a geriatric-specific 
513  indication:   
514   
515    INDICATIONS AND USAGE:  All geriatric indications supported by adequate and 
516  well-controlled studies in geriatric patients must be included in the INDICATIONS AND 
517  USAGE section.59  If the drug is indicated for use only in geriatric patients, in general, 
518  the FDA recommends using the phrases patients XX years of age and older, adults 
519  XX years of age and older, or similar phrases in the indication.  For example: 
520   
521  DRUG X is indicated for the treatment of Indication A in patients 65 years of age 
522  and older. 
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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524    DOSAGE AND ADMINISTRATION:  This section must include the recommended 
525  dosage in geriatric patients for all approved geriatric-specific indications.60 
526   
527    ADVERSE REACTIONS:  Geriatric adverse reaction data must be included in the 
528  ADVERSE REACTIONS section.61   
529   
530    USE IN SPECIFIC POPULATIONS, Geriatric Use subsection:  Only a summary 
531  statement of the approved geriatric indication(s) should be described in the Geriatric Use 
532  subsection.  For example: 
533   
534  DRUG X is indicated in patients 65 years of age and older (for Indication A), and 
535  the information on this use is discussed throughout the labeling. 
536   
537    CLINICAL PHARMACOLOGY:  Data summarized in the Geriatric Use subsection 
538  must be discussed in more detail, if appropriate, in the CLINICAL PHARMACOLOGY 
539  section.62  Detailed descriptions of geriatric pharmacokinetic, pharmacodynamic, and/or 
540  pharmacogenomic study data; relevant data obtained from population analyses; and dose 
541  response information should be included in this section.63   
542   
543    CLINICAL STUDIES:  Data summarized in the Geriatric Use subsection must be 
544  discussed in more detail, if appropriate, in the CLINICAL STUDIES section.64  Detailed 
545  descriptions of studies that provide substantial evidence of effectiveness for use in 
546  geriatric patients (e.g., study design(s), population(s), endpoint(s), results and limitations 
547  of the study design or evidence) should be provided in this section.65  
548   
549   
550  VI.  DRUG IS NOT APPROVED IN THE GERIATRIC POPULATION 
551   
552  Drugs that are studied only in younger adult patients (not geriatric patients) are typically 
553  approved for all adult patients (including geriatric patients) because of generalizability of the 
554  evidence to geriatric patients, consistencies in the disease processes across geriatric and younger 
555  adults, and the drugs overall benefits and risks.  However, there are uncommon situations when 
556  the evidence does not support the use of a drug in a geriatric population because clinical studies 
                                                 
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). 
 
65See 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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557  did not include a sufficient number of geriatric patients to support geriatric use for an 
558  indication.66  Additionally, there are uncommon situations when the evidence does not support 
559  the use of a drug in a geriatric population because the results of studies conducted in a geriatric 
560  population strongly suggest that the drug is ineffective or the benefit-risk profile is unfavorable 
561  (but the evidence falls short of warranting a contraindication).67 
562   
563  We recommend applicants contact the Agency if they have questions about developing labeling 
564  for these uncommon situations.   
565   
566  If the use of the drug in geriatric patients is associated with a risk or safety concern (hazard) in 
567  geriatric patients, the risk or safety concern must be described in the Geriatric Use subsection or, 
568  if appropriate, must be stated in the CONTRAINDICATIONS and/or WARNINGS AND 
569  PRECAUTIONS section(s), and the Geriatric Use subsection must cross-reference the section or 
570  sections, if appropriate.68  Any such hazard must be stated in other sections of labeling (e.g., 
571  BOXED WARNING), as appropriate.69   
572   
573   
574  VII.  OMITTING OR REVISING INFORMATION AND UPDATING LABELING 
575   
576  If an applicant believes that none of the requirements described in 21 CFR 201.57(c)(9)(v)(A) to 
577  (E) is appropriate or relevant to its drugs labeling, the applicant must provide a rationale for 
578  omission of the statement(s) and may propose an alternative statement.70  The FDA may permit 
579  omission of such statement(s) or alternative appropriate and accurate statement(s) if the FDA 
580  determines that no statement(s) described in 21 CFR 201.57(c)(9)(v)(A) to (E) are appropriate or 
581  relevant to the drugs labeling.71  In some circumstances, applicants should omit specific 
582  information otherwise required in the Geriatric Use subsection or omit the entire subsection 
583  because the information is clearly inapplicable; applicants must omit such specific information or 
                                                 
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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584  the entire subsection if it is misleading.72  For example, if a drug is indicated for use only in 
585  neonates, the applicant should omit the Geriatric Use subsection because this subsection is 
586  clearly inapplicable.  We recommend applicants contact the Agency if they have questions about 
587  omitting certain regulatory statements in the Geriatric Use subsection. 
588   
589  Labeling must be updated when new information becomes available that causes the labeling to 
590  become inaccurate, false, or misleading.73  Consistent with this requirement, when revising 
591  existing information in the labeling, applicants should evaluate labeling content to ensure that it 
592  accurately reflects current knowledge about the use of the drug in geriatric patients for all 
593  approved indications.  Applicants should evaluate available results from postmarketing 
594  controlled clinical studies, well-documented studies obtained from a literature search that are 
595  available to the applicant and reasonably relevant to the use of the drug in geriatric patients, 
596  pharmacokinetic and pharmacodynamic studies conducted in geriatric patients, and adverse 
597  event reports.74  Applicants should review and update sections of labeling pertinent to the 
598  geriatric use information as necessary when updating the labeling. 
                                                 
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. 
  18