Postmarketing Approaches to 
Obtain Data on Populations 
Underrepresented in Clinical 
Trials for Drugs and Biological 
Products 
 
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DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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 (OCE/CDER) Nicole Gormley 240-402-
0210, or (CBER) Office of Communication, Outreach, and Development, 800-835-4709 or 240-
402-8010. 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Oncology Center of Excellence (OCE) 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
August 2023 
Clinical/Medical 
   
Postmarketing Approaches to 
Obtain Data on Populations 
Underrepresented in Clinical 
Trials for Drugs and Biological 
Products 
Guidance for Industry 
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
and/or 
Office of Communication, Outreach, and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Oncology Center of Excellence (OCE) 
Center for Drug Evaluation and Research (CDER) 
Center of Biologics Evaluation and Research (CBER) 
August 2023 
Clinical/ Medical 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  MECHANISMS FOR OBTAINING POSTMARKETING DATA ON 
UNDERREPRESENTED POPULATIONS ............................................................................... 3 
A.  PMRs ............................................................................................................................................... 4 
B.  PMCs ............................................................................................................................................... 5 
IV.  STUDY DESIGN AND STATISTICAL CONSIDERATIONS .................................... 5 
A.  Considerations for Single-Arm Trials .......................................................................................... 5 
B.  Considerations for Randomized Trials ........................................................................................ 6 
C.  Real-World Data (RWD) Sources ................................................................................................ 6 
D.  Pooled Studies ................................................................................................................................ 6 
V.  POSTMARKETING APPROACHES TO OBTAIN DATA ON 
UNDERREPRESENTED POPULATIONS AND OTHER CONSIDERATIONS ................ 7 
A.  Develop recruitment strategies tailored to the intended population ......................................... 7 
B.  Foreign Clinical Data ..................................................................................................................... 8 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Postmarketing Approaches to Obtain Data on Populations 
2  Underrepresented in Clinical Trials for Drugs and Biological 
3  Products 
4  Guidance for Industry1 
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   
16  I.  INTRODUCTION 
17   
18  FDA regulations require sponsors to present information from premarket clinical trials on the 
19  safety and effectiveness of drugs2 in terms of gender, age, and racial subgroups.3,4  These clinical 
20  trials should include patient populations that are historically underrepresented in clinical research 
21  (e.g., populations based on race, ethnicity, sex, or age.)5  However, if, despite the sponsors best 
22  efforts, these populations are not adequately represented in premarket clinical trials, it may be 
23  appropriate to collect such data in the postmarketing setting.  The purpose of this guidance is to 
24  describe FDA requirements and provide recommendations for obtaining safety and effectiveness 
25  information on drugs, when appropriate, in the postmarketing setting in historically 
26  underrepresented patient populations in clinical trials. 
27   
28  Specifically, this guidance will discuss the following: 
29   
30    Mechanisms by which FDA can require or request information on safety and 
31  effectiveness be collected in the postmarketing setting 
32    Design and statistical considerations for subpopulation analyses 
 
1 This guidance has been prepared by the Oncology Center of Excellence in cooperation with the Center for Drug 
Evaluation and Research and the Center for Biologics Evaluation and Research at the Food and Drug 
Administration.  
2 This guidance applies to drugs, including biological products.  For the purposes of this guidance, drug or drug 
product is used to refer to human drugs and human biological products that are regulated as drugs. 
3 See 21 CFR 314.50(d)(5)(v)-(vi); 21 CFR 312.33(a)(2).  
4 See also section 505(z) of the FD&C Act, which would require sponsors to submit a diversity action plan for a 
phase 3 study or other pivotal study of a drug.  This requirement will apply with respect to clinical investigations for 
which enrollment commences 180 days after the publication of a final guidance on diversity action plans.  FDA will 
also hold public workshops on this matter. 
5 This list is not all inclusive.  Efforts should be made, whether in the premarket or postmarketing setting, to include 
other underrepresented populations including but not limited to, geographic location, gender identity, socioeconomic 
status, disability, pregnancy status, lactation status, and co-morbidity. 
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Draft  Not for Implementation 
33    Postmarketing approaches to obtain information on the benefit-risk profile in 
34  underrepresented clinical trial populations 
35   
36  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
37  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
38  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
39  the word should in Agency guidances means that something is suggested or recommended, but 
40  not required 
41   
42  II.  BACKGROUND 
43   
44  Having information on the safety and efficacy of a drug across a diverse patient population is 
45  important to support the generalizability of the results to the broad patient population expected to 
46  take a drug if it is FDA-approved.  Disease occurrence and outcome may vary based on 
47  associated demographic factors such as race, ethnicity, sex, or age, among others.  Toxicity due 
48  to the drug may also differentially occur in relation to these factors.  Such differences may occur 
49  due to intrinsic factors (e.g., genetics, metabolism, elimination, physiologic changes), extrinsic 
50  factors (e.g., diet, environmental exposure, socioeconomic status, culture), or interactions among 
51  these factors.6 
52   
53  Reviews of clinical trial data indicate that there is persistent under-representation of patient 
54  populations, based on race, ethnicity, sex, or age7,8,9,10,11.  FDA has published various guidance 
55  documents to improve diversity in clinical trials including Collection of Race and Ethnicity Data 
56  in Clinical Trials (October 2016); Enhancing the Diversity of Clinical Trial Populations  
57  Eligibility Criteria, Enrollment Practices, and Trial Designs (November 2020); and Inclusion of 
58  Older Adults in Cancer Clinical Trials (March 2022).  Additionally, FDA has sponsored 
 
6 ICH Harmonized Tripartite Guideline: Ethnic Factors in the Acceptability of Foreign Clinical Data. E5(R1), at 
https://database.ich.org/sites/default/files/E5_R1__Guideline.pdf  
7 Bhatnagar V, Gormley N, Kazadjian D, Goldberg K, McKee A, Blumenthal G, Farrell AT, Pazdur R. FDA 
Analysis of Racial Demographics in Multiple Myeloma Trials. Blood. 2017;130:4352. 
8 Singh H, Kanapuru B, Smith C, Fashoyin-Aje LA, Myers A, Kim G, Pazdur R. FDA Analysis of Enrollment of 
Older Adults in Clinical Trials for Cancer Drug Registration: A 10-Year Experience by the U.S. Food and Drug 
Administration. J Clin Oncol. 2017;35:15 suppl, 10009. 
9 Kanapuru B, et al. FDA Analysis of MM. In press 
10 Gifford AL, Cunningham WE, Heslin KC, Andersen RM, Nakazono T, Lieu DK, Shapiro MF, Bozzette SA; HIV 
Cost and Services Utilization Study Consortium. Participation in research and access to experimental treatments by 
HIV-infected patients. N Engl J Med. 2002;346(18):1373-82. 
11 Strong B, Pudar J, Thrift AG, Howard VJ, Hussain M, Carcel C, de Los Campos G, Reeves MJ. Sex Disparities in 
Enrollment in Recent Randomized Clinical Trials of Acute Stroke: A Meta-analysis. JAMA Neurol. 
2021;78(6):666677. 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
59  multiple public workshops12,13,14 to further engage with the broader community on the 
60  importance of diverse representation in clinical trials.  FDA encourages efforts to include 
61  underrepresented populations in clinical trials, including populations based on race, ethnicity, 
62  sex, age, geographic location, gender identity, socioeconomic status, disability, pregnancy status, 
63  lactation status, and co-morbidity. 
64   
65  The Agency strongly recommends sponsors obtain information from a diverse, representative 
66  patient population early in drug development before initial approval but recognizes that in certain 
67  circumstances this information may be limited and must be balanced within the benefit-risk 
68  framework, including whether there is unmet medical need and the importance of the product 
69  within the overall therapeutic armamentarium.15  Obtaining information early in development 
70  can be advantageous in that information about differential pharmacokinetics (PK), 
71  pharmacodynamics (PD), efficacy, or safety may help inform subsequent clinical trials and, 
72  ultimately, result in more efficient, informative, and successful drug development.  However, if 
73  despite the sponsors best efforts, such information could not be obtained prior to initial approval 
74  of a drug, this information can be obtained in the postmarketing setting.  
75   
76  III.  MECHANISMS FOR OBTAINING POSTMARKETING DATA ON 
77  UNDERREPRESENTED POPULATIONS 
78   
79  There are various mechanisms for obtaining postmarketing data on underrepresented 
80  populations.  FDA may require an applicant to conduct postapproval studies or clinical trials16 as 
81  a postmarketing requirement (PMR) where the statutory criteria are met,17 or FDA may enter 
82  into a written agreement with the applicant to collect these data as a postmarketing commitment 
83  (PMC).18  Section 505(o)(3)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
84  requires an applicant to provide certain information to FDA about its PMR, including a timetable 
85  for study or clinical trial completion and periodic reports on the status of the study or clinical 
 
12 Levit L, Singh H, Klepin H, Hurria A, 2018, Expanding the Evidence Base in Geriatric Oncology: Action Items 
from an FDA-ASCO Workshop. J Natl Cancer Inst. 2018. 110(11):1163-1170. 
13 FDA Workshop Roadmap to 2030 for New Drug Evaluation in Older Adults. 2021 Mar 23: 
https://www.fda.gov/drugs/news-events-human-drugs/roadmap-2030-new-drug-evaluation-older-adults-03232021-
03232021. 
14 FDA-AACR Workshop to Examine Under-representation of African Americans in Multiple Myeloma Clinical 
Trials. 2021 Feb 13: https://www.fda.gov/drugs/fda-aacr-workshop-examine-under-representation-african-
americans-multiple-myeloma-clinical-trials. 
15 See also section 505(z) of the FD&C Act, which would require sponsors to submit a diversity action plan for an 
applicable phase 3 study or other pivotal study of a drug. 
16 For the purposes of implementing section 505(o)(3) of the FD&C Act, FDA defines clinical trials as any 
prospective investigations in which the applicant or investigator determines the method of assigning the drug 
product(s) or other intereventions to one or more human subjects and defines clinical studies as all other 
investigations, such as investigations with human that are not clinical trials (e.g., observational epidemiologic 
studies) animal studies, and laboratory experiments.  
17 See, e.g., section 505(o)(3) and 506 of the FD&C Act; see also draft guidance for industry Postmarketing Studies 
and Clinical Trials-Implementation of 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (October 2019).  
When final, this guidance will represent FDAs current thinking on this topic.  We update guidances periodically.  
For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents. 
18 See section 506B of the FD&C Act; 21 CFR 314.81, 601.70.  
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
86  trial.19  Additionally, Section 506B of the FD&C Act provides FDA with the authority to 
87  monitor the progress of certain postmarketing studies by requiring the applicant to submit a 
88  report annually that provides information on the status of such studies.20  Before requiring a 
89  postmarketing study or clinical trial under Section 505(o)(3), FDA must find that adverse event 
90  reporting under Section 505(k)(1) of the FD&C Act and the active risk identification and 
91  analysis (ARIA) system under section 505(k)(3) of the FD&C Act will not be sufficient (1) to 
92  assess a known serious risk related to the use of the drug; (2) to assess signals of serious risk 
93  related to use of the drug; or (3) to identify an unexpected serious risk when available data 
94  indicates the potential for a serious risk.21  Further, before requiring a postmarketing clinical 
95  trial, FDA must find that a postmarketing study or studies will not be sufficient to meet those 
96  purposes.22 
97   
98  If the drug is to be granted accelerated approval, FDA has required confirmation of clinical 
99  benefit in a confirmatory trial.23  The confirmatory trial should represent the diversity of patients 
100  expected to use the drug in the United States.  
101   
102  A.  PMRs  
103  If adverse event reporting and ARIA are determined to be insufficient under Section 
104  505(o)(3) of the FD&C Act, FDA can require applicants to conduct postmarketing studies 
105  or, as applicable, clinical trials for a drug product either at the time of or after approval.24  
106  FDA can require PMRs to assess a known serious risk, signals of a serious risk, or to 
107  identify an unexpected serious risk when data indicate the potential for a serious risk.25  This 
108  includes postmarketing studies or, as applicable, clinical trials to further assess or identify a 
109  serious risk related to failure of expected pharmacological action, including reduced 
110  effectiveness under the conditions of use prescribed in labeling, but which may not include 
111  reduced effectiveness that is in accordance with such labeling.26 
112   
113  For example, FDA may require an applicant to evaluate the incidence rates of certain serious 
114  adverse events among U.S. racial and ethnic minorities or older patients when there are data 
115  to suggest that those adverse events may occur at a higher rate in these populations but an 
116  insufficient number of participants from these populations participated in the pivotal trial to 
117  adequately evaluate the signal.  This may include evaluation of a potential serious risk 
118  related to reduced effectiveness in a subpopulation of patients (e.g., defined by race, 
119  ethnicity, sex or age) compared to the overall populations.  For example, FDA may require a 
 
19 Section 505(o)(3)(E) of the FD&C Act.  
20 Section 506B of the FD&C Act; see also guidance for industry Reports on the Status of Postmarketing Study 
Commitments  Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 
(February 2006). 
21 Section 505(o)(3)(B) and (D)(i) of the FD&C Act. 
22 Section 505(o)(3)(B) and (D)(ii) of the FD&C Act; see also draft guidance for industry Postmarketing Studies and 
Clinical Trials-Implementation of 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (October 2019).  When 
final, this guidance will represent FDAs current thinking on this topic. 
23 Section 506(c)(3)(A) of the FD&C Act and 21 CFR 314.510 and 601.41.  See also guidance for industry 
Expedited Programs for Serious Conditions  Drugs and Biologics (May 2014). 
24 Section 505(o)(3)(D) of the FD&C Act.  
25 Section 505(o)(3)(B) and (D) of the FD&C Act. 
26 See section 505(o)(3) and 505-1(b) of the FD&C Act.  
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120  PMR if there is data to suggest a signal of a serious risk related to reduced effectiveness in 
121  an underrepresented population or a subgroup of patients with a particular genetic mutation 
122  that occurs more commonly in patients of a particular race.  
123   
124  B.  PMCs 
125  FDA may enter into a written agreement with the applicant to conduct postmarketing studies 
126  and clinical trials under a PMC.  In some cases, underrepresentation of certain sub-
127  population in clinical trials can lead to a lack of data on the sub-population.  FDA may enter 
128  into a written agreement with the applicant to collect data from clinical trials, postmarketing 
129  studies, or additional data sources to further characterize clinical benefit or safety in those 
130  sub-populations under a PMC.  For example, if there is a lack of data in a certain 
131  subpopulation of patients (e.g., defined by race, ethnicity, sex, age), FDA may enter into a 
132  written agreement with the applicant to collect data under a PMC to obtain additional safety 
133  and efficacy data in that subpopulation. 
134   
135   
136  IV.  STUDY DESIGN AND STATISTICAL CONSIDERATIONS  
137   
138  The sections below describe design and statistical considerations for various postmarketing 
139  approaches to provide additional information regarding traditionally under-represented 
140  populations.  
141   
142  A.  Considerations for Single-Arm Trials   
143    Single-arm trials can be designed with a sample size calculation intended to rule out a 
144  historical rate of safety or efficacy to help provide assurance that the medical product 
145  is safe and effective in the relevant subpopulation(s). 
146    Single-arm trials can use a Bayesian posterior probability model to exclude the 
147  historical rate at pre-specified levels, e.g., 90 percent or higher.  
148    Single-arm trial designs can also allow for borrowing of patients from the pre-
149  approval study(ies) when appropriate to obtain a larger sample size of the 
150  subpopulation of interest.  
151    Single arm trials should collect PK and PD (if applicable) information to inform or 
152  understand any differences in the subpopulation of interest detected in the 
153  registrational studies. 
154    Single arm trials can enroll and analyze subpopulations underrepresented in the main 
155  analysis population in a separate cohort as a parallel arm of the trial.  When clinically 
156  appropriate, the separate cohort may be opened/closed simultaneously with the main 
157  cohort or in an asynchronous manner.  In some cases, the separate cohort can be 
158  actively accruing at the time of the new drug application (NDA) or biologics license 
159  application (BLA) submission.  For example, if the separate cohort is evaluating a 
160  group at high risk for toxicity, the cohort may open after the primary analysis portion 
161  of the trial to obtain more safety information prior to enrollment of the higher risk 
162  population.  Alternatively, the separate cohort may remain open after the primary 
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Draft  Not for Implementation 
163  analysis population to allow for enrollment of a larger number of patients from the 
164  underrepresented population. 
165   
166  B.  Considerations for Randomized Trials  
167    Randomized trials that are planned at the time of the NDA or BLA submission may 
168  be revised to enrich the trial for the subpopulation(s) of interest to obtain 
169  postmarketing data.  Trials that are ongoing at the time of the NDA or BLA 
170  submission may also be modified in some cases, but it is important to consider and 
171  discuss with the Agency the rationale for the potential changes and any impact on 
172  statistical analyses.27 
173    Sponsors could also stratify based on the subpopulation(s) of interest if there are 
174  potential prognostic implications associated with the subpopulation.  For example, a 
175  trial can stratify based on race, ethnicity, sex, age, or a hypothesized difference in 
176  efficacy in the population of interest versus the general population, so that analyses 
177  can focus on benefits and risks in the underrepresented population. 
178    The trial should collect adequate PK and PD information (if applicable) to inform or 
179  understand any differences in the subpopulation(s) of interest.  
180   
181  C.  Real-World Data (RWD) Sources  
182    Real world data,28 including electronic health records29,30 and registries,31 can be 
183  used to provide postmarketing data when appropriate.  Sponsors should carefully 
184  assess the adequacy of the RWD to appropriately answer the questions relevant to 
185  the subpopulation(s) of interest (e.g., ensuring the RWD source is fit for purpose). 
186    There are multiple complex issues when considering the use of RWD to obtain 
187  postmarketing information on traditionally underrepresented populations.  The 
188  Agency recommends that sponsors discuss the proposed use of RWD with the FDA 
189  review division to obtain feedback and guidance early in their development.  
190   
191  D.  Pooled Studies 
192    Meta-analyses of randomized trials can be conducted to obtain postmarketing data 
193  provided similarly designed trials evaluating the drug are available with sufficient 
 
27 See guidance for industry Adaptive Design Clinical Trials for Drugs and Biologics (December 2019) 
28 Refer to FDAs Framework for FDAs Real-World Evidence Program (December 2018)  
29 See draft guidance for industry Real-World Data: Assessing Electronic Health Reords and Medical Claims Data 
to Support Regulatory Decision-Making for Drug and Biological Products (September 2021).  When final, this 
guidance will represent FDAs current thinking on this topic. 
30 See guidance for industry Use of Electronic Health Record Data in Clinical Investigations (July 2018) 
31 See draft guidance for industry Real-World Data: Assessing Registries to Support Regulatory Decision-Making 
for Drug and Biological Products (November 2021).  When final, this guidance will represent FDAs current 
thinking on this topic.  
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Draft  Not for Implementation 
194  enrollment of the subpopulation of interest, and comparable drug exposure across the 
195  selected studies and therapeutic indications.32  
196    Pooling data across trials, if methodologically appropriate, may allow for a 
197  meaningful evaluation of the drug in patients from different clinically relevant 
198  subpopulations if the clinical studies include an adequate number of patients and 
199  sufficient data (PK, PD, efficacy, and safety) from each subpopulation is collected.  
200  Sponsors should discuss with the relevant review division what may be considered 
201  adequate representation to answer the questions of interest for a specific 
202  development program. 
203  V.  POSTMARKETING APPROACHES TO OBTAIN DATA ON 
204  UNDERREPRESENTED POPULATIONS AND OTHER CONSIDERATIONS 
205   
206  The sponsors approach to provide information on underrepresented populations should be 
207  discussed with the FDA review division early in a product development program.  FDA 
208  recommends submission of a diversity plan as outlined in the guidance for industry, Diversity 
209  Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic 
210  Populations in Clinical Trials.33,34  As noted above, the sponsor and FDA should work 
211  together to determine appropriate benchmarks for an inclusive and representative data 
212  package that is specific to each development plan.  If during the course of the clinical 
213  development program, the strategies implemented to recruit and retain a representative 
214  population appear unlikely to accomplish the intended objective despite best efforts, the 
215  sponsor and FDA should discuss next steps.  If it is determined that additional information 
216  should be collected in the postmarketing period, such data can provide clinically useful 
217  information and can potentially be added to drug labeling, when appropriate.  
218   
219  A.  Develop recruitment strategies tailored to the intended population  
220   
221  The guidance for industry, Enhancing the Diversity of Clinical Trial Populations  
222  Eligibility Criteria, Enrollment Practices, and Trial Designs (November 2020) includes 
223  recommendations for inclusive trial practices, trial design and methodological 
224  approaches, and other study design and conduct considerations for improving enrollment 
225  that sponsors should consider regarding underrepresented populations.  The same 
226  guidance discusses the importance of clinical trial site selection to allow for recruitment 
 
32 See 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 FDAs current 
thinking on this topic. 
33 See draft guidance for industry Diversity Plans to Improve Enrollment of Participants from Underrepresented 
Racial and Ethnic Populations in Clinical Trials (April 2022).  When final, this guidance will represent FDAs 
current thinking on this topic. 
34 See also section 505(z) of the FD&C Act, which would require sponsors to submit a diversity action plan for a 
phase 3 study or other pivotal study of a drug.  This requirement will apply with respect to clinical investigations for 
which enrollment commences 180 days after the publication of a final guidance on diversity action plans.  FDA will 
also hold public workshops on this matter. 
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Draft  Not for Implementation 
227  of a more diverse study population.  These consideration would be applicable to trials 
228  conducted in the post-marketing setting. 
229   
230  B.  Foreign Clinical Data 
231   
232  Under 21 CFR 314.106, FDA may approve a marketing application based solely on 
233  foreign clinical data if, among other factors, the data are applicable to the U.S. population 
234  and U.S. medical practice.  If a sponsor submits a marketing application comprised of 
235  patients enrolled predominantly outside of the United States, data and rationale should be 
236  submitted to support applicability to the U.S. population and medical practice.  FDA may 
237  request or require studies or trials to further characterize the efficacy or safety of the 
238  product in subpopulations relevant to the U.S. population. 
  8