Collection of Race and Ethnicity Data in 
Clinical Trials and Clinical Studies for 
FDA-Regulated Medical 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DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only.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 90 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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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) CDEROMP@fda.hhs.gov, 301-
796-2500; (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 
240-402-8010; or (OMHHE) Office of Minority Health and Health Equity, 
healthequity@fda.hhs.gov. 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of the Commissioner (OC) 
Office of Minority Health and Health Equity (OMHHE) 
Office of Womens Health (OWH) 
Office of Clinical Policy (OCLiP) 
Office of Pediatric Therapeutics (OPT) 
Center for Drug Evaluation and Research (CDER)  
Center for Biologics Evaluation and Research (CBER)  
Center for Devices and Radiologic Health (CDRH) 
Oncology Center of Excellence (OCE) 
             
January 2024 
Clinical/Medical 
Revision 1 
 
45585115dftrv1.docx    
Collection of Race and Ethnicity Data in Clinical Trials 
and Clinical Studies for FDA-Regulated Medical 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  
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Email: druginfo@fda.hhs.gov  
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and/or 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
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Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances     
and/or 
Office of Policy 
Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 66, Room 5431 
Silver Spring, MD 20993-0002 
Email: CDRH-Guidance@fda.hhs.gov 
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-
and-radiation-emitting-products  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of the Commissioner (OC) 
Office of Minority Health and Health Equity (OMHHE) 
Office of Womens Health (OWH) 
Office of Clinical Policy (OCLiP) 
Office of Pediatric Therapeutics (OPT) 
Center for Drug Evaluation and Research (CDER)  
Center for Biologics Evaluation and Research (CBER)  
Center for Devices and Radiologic Health (CDRH) 
Oncology Center of Excellence (OCE) 
 
January 2024 
Clinical/Medical 
Revision 1 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 4 
III.  COLLECTING RACE AND ETHNICITY DATA IN CLINICAL TRIALS AND 
CLINICAL STUDIES .................................................................................................................. 5 
A.  Two-Question Format ...................................................................................................... 5 
B.  Self-Reporting ................................................................................................................... 5 
C.  Ethnicity ............................................................................................................................. 5 
D.  Race .................................................................................................................................... 6 
E.  Use of More-Detailed Racial and Ethnic Categories ..................................................... 6 
IV.  PRESENTATION OF RACE AND ETHNICITY DATA IN CLINICAL TRIALS AND 
CLINICAL STUDIES ...................................................................................................................... 7 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Collection of Race and Ethnicity Data in Clinical Trials and Clinical 
2  Studies for FDA-Regulated Medical Products 
3  Guidance for Industry1 
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 
8  and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
9  requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
10  contact the FDA staff responsible for this guidance as listed on the title page.   
11   
12   
13   
14   
15  I.  INTRODUCTION  
16   
17  The purpose of this guidance is to provide FDAs expectations for, and recommendations on, use 
18  of a standardized approach for collecting and reporting race and ethnicity data in submissions 
19  including information collected and reported from clinical trials and clinical studies2 for FDA-
20  regulated medical products.3,4  Using standard terminology for race and ethnicity helps ensure 
21  that data are collected and reported consistently in submissions to FDA.  FDAs recommended 
22  approach is based on the Office of Management and Budget (OMB) Statistical Policy Directive 
23  No. 15 (Policy Directive 15)5 and was developed in accordance with section 4302 of the 
24  Affordable Care Act;6 the Health and Human Services (HHS) Implementation Guidance on Data 
 
1This guidance has been developed by the Office of the Commissioner, the Office of Minority Heath and Health 
Equity, the Office of Womens Health, the Office of Clinical Policy, the Office of Pediatric Therapeutics, the Center 
for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Center for Devices and 
Radiological Health, and the Oncology Center of Excellence at the Food and Drug Administration. 
2 Going forward in this guidance, we use the term clinical studies to refer broadly to research that evaluates human 
health outcomes associated with the use of medical products.  We use the term clinical studies to include 
interventional (clinical trial) and non-interventional (observational) designs.  Some recommendations in this 
guidance are specific to clinical trials and are identified as such when relevant.  
3 See the guidance for industry Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical 
Device Clinical Studies (September 2017).  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. 
4 For the purposes of this guidance, the term medical products refers to drugs, including biological products, and 
devices as defined by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301392) unless otherwise specified. 
5 OMB Statistical Policy Directive No. 15, Revisions to the Standards for the Classification of Federal Data on Race 
and Ethnicity (Policy Directive 15) (October 30, 1997), available at 
https://obamawhitehouse.archives.gov/omb/fedreg_1997standards. 
6 Patient Protection and Affordable Care Act, Public Law 111148, section 4302 (42 U.S.C. 300kk) (March 23, 
2010), available at https://www.gpo.gov/fdsys/pkg/CREC-2009-11-19/pdf/CREC-2009-11-19-pt1-PgS11607- 
3.pdf#page=127. 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
25  Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status;7 and the 
26  Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan.8  
27  This guidance revises the guidance for industry and FDA staff Collection of Race and Ethnicity 
28  Data in Clinical Trials issued in October 2016.  When finalized, this guidance will replace the 
29  October 2016 guidance. 
30   
31  Current OMB standards for the classification of Federal data on race and ethnicity were 
32  developed to provide a common framework for uniformity and consistency in the collection and 
33  use of data on race and ethnicity by Federal Agencies.   
34   
35  On January 27, 2023, OMB announced a formal review of OMB Policy Directive 15 and 
36  requested public comments on initial proposals to revise the directive to account for large 
37  societal, political, and economic demographic shifts in the United States over the 25 years since 
38  its publication.9  FDA began the process to update this guidance before the OMB announcement.  
39  FDA continued the process to update this guidance, including updating references and contact 
40  information for FDA and revising the title, to ensure the appropriate collection and reporting of 
41  race and ethnicity data in submissions from clinical studies and clinical trials for FDA-regulated 
42  medical products.  FDA will update this guidance as appropriate if OMB revises Policy 
43  Directive 15. 
44   
45  This guidance provides recommendations on: 
46   
47  1.  Meeting the requirements set forth in the 1998 final rule10 regarding presentation of 
48  demographic data in investigational new drug applications (INDs) and new drug 
49  applications (NDAs) (known as the Demographic Rule)  
50   
51  2.  Collection of race and ethnicity data in biologics license applications (BLAs) and medical 
52  device applications11 
53   
54  3.  Addressing the FDASIA Section 907 Action Plan to improve the completeness and 
55  quality of demographic data collection and reporting 
56   
 
7 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and 
Disability Status (October 31, 2011), available at https://aspe.hhs.gov/reports/hhs-implementation-guidance-data-
collection-standards-race-ethnicity-sex-primary-language-disability-0. 
8 See the FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data (FDASIA 
Section 907 Action Plan), August 2014, available at https://www.fda.gov/media/89307/download. 
9 See OMB Federal Register notice (88 FR 5375),  https://www.federalregister.gov/documents/2023/01/27/2023-
01635/initial-proposals-for-updating-ombs-race-and-ethnicity-statistical-standards. 
10 1998 final rule, Investigational New Drug Applications and New Drug Applications (the Demographic Rule), 
see 63 FR 6854 (February 11, 1998) (codified at 21 CFR 312.33(a)(2) and 21 CFR 314.50(d)(5)), available at 
https://www.gpo.gov/fdsys/pkg/FR-1998-02-11/pdf/98-3422.pdf. 
11 For medical devices, see also the guidance for industry and FDA staff Evaluation and Reporting of Age-, Race-, 
and Ethnicity-Specific Data in Medical Device Clinical Studies. 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
57  For drugs, the Demographic Rule requires the sponsor of an IND to tabulate in an IND annual 
58  report the number of participants enrolled in the clinical trial by certain demographic subgroups 
59  including race and requires NDA submissions to include summaries of effectiveness and safety 
60  data for demographic subgroups, including racial subgroups.12  FDA also strongly recommends 
61  the collection and reporting of ethnicity data (Hispanic or Latino or not Hispanic or Latino) 
62  consistent with OMB standards.13  
63   
64  This guidance is also intended to help an applicant preparing a BLA or a device premarket 
65  submission, which should be done in accordance with the OMB standards regarding collection 
66  and reporting of race and ethnicity data described herein.14 
67   
68  This guidance also recommends the use of the OMB race and ethnicity categories in proposed 
69  medical product labeling.   
70    
71  Sponsors of investigational new drugs and investigational devices should enroll participants who 
72  reflect the population that will use the medical product if approved.15  Sections 505(z) and 
73  520(g) of the Federal Food, Drug, and Cosmetic Act, as amended by section 3601 of the Food 
74  and Drug Omnibus Reform Act of 2022 (FDORA) require that such sponsors submit a diversity 
75  action plan outlining (1) the sponsors goals for enrollment in the clinical trial, (2) the sponsors 
76  rationale for such goals, and (3) an explanation of how the sponsor intends to meet such goals.  
77  As described in section 3602 of FDORA, this requirement will apply with respect to clinical 
78  trials for medical products for which enrollment commences 180 days after the publication of a 
79  final guidance on diversity action plans.16  This guidance does not address diversity action plans 
80  or the appropriate population for a clinical study.  For questions related to enrollment of 
81  clinically relevant demographic subpopulations in clinical trials, sponsors should consult with the 
82  review division of the appropriate centers and offices.17  
83   
84  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
85  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
86  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
87  the word should in Agency guidances means that something is suggested or recommended, but 
88  not required. 
89   
90   
 
12 See footnote 10. 
13 See footnote 5. 
14 Ibid. 
15 See also the guidance for industry Enhancing the Diversity of Clinical Trial Populations  Eligibility Criteria, 
Enrollment Practices, and Trial Designs (November 2020). 
 
16 See Food and Drug Omnibus Reform Act of 2022 (FDORA) available at 
https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf. 
 
17 See also the 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. 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
91  II.  BACKGROUND 
92   
93  Although uncommon, differences in response to medical products have been observed in racially 
94  and ethnically distinct populations in the United States.18  In some cases, differences in the 
95  pharmacokinetics, efficacy, or safety of medical products that lead to these different responses 
96  may be attributable to intrinsic factors (e.g., genetics, metabolism, elimination, skin 
97  pigmentation), extrinsic factors (e.g., diet, environmental exposure, socioeconomic status, 
98  culture), or interactions between these factors.19  Collecting data on race and ethnicity is critical 
99  to identifying population-specific signals.   
100   
101  In 1997, OMB issued its revised recommendations for the collection and use of race and 
102  ethnicity data by Federal Agencies (Policy Directive 15).20  OMB stated that the recommended 
103  race and ethnicity categories were not anthropologically or scientifically based designations, but 
104  instead are categories that describe the sociocultural construct of our society. 
105   
106  In 1999, HHS issued the report Improving the Collection and Use of Racial and Ethnic Data in 
107  HHS.21  The report describes HHS policy on collecting and reporting data on race and ethnicity 
108  for HHS programs.  The report recommends inclusion of race and ethnicity categories in HHS-
109  funded and sponsored data collection and reporting systems in all HHS programs to (1) help 
110  monitor HHS programs, (2) determine whether Federal funds are being used in a 
111  nondiscriminatory manner, and (3) promote the availability of standard race and ethnicity data 
112  across various agencies to facilitate HHS responses to major health and human services issues. 
113  This policy, updated in 2011,22 states that the minimum standard categories in OMB Policy 
114  Directive 15 should be used when collecting and reporting data in HHS data systems or when 
115  reporting HHS-funded statistics.  On September 21, 2016, HHS issued the final rule, Clinical 
116  Trials Registration and Results Information Submission (81 FR 64982) (42 CFR part 11).  The 
117  final rule requires the submission of race and ethnicity information with summary results 
118  information if it is collected during the trial.  
119   
120     
 
18 For example, in 2005, FDA approved BiDil (isosorbide dinitrate and hydralazine hydrochloride tablets), the first 
drug approved by the Agency to treat a disease only in patients who identified by a specific racial subgroup.  BiDil 
is approved for the treatment of heart failure as an adjunct to standard therapy in self-identified Black patients to 
improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional 
status.  Although the sponsors initial two trials in certain patients with heart failure failed to show a benefit in the 
overall population (sum of all racial groups), there was a suggestion of benefit of BiDil in one racial subgroup (i.e., 
Black patients).  In a subsequent study in 1,050 self-identified Black patients with a certain type of heart failure, 
BiDil was shown to be safe and effective for the treatment of heart failure as an adjunct to standard therapy.  
19 Ramamoorthy A, MA Pacanowski, J Bull, L Zhang, 2015, Racial/Ethnic Differences in Drug Disposition and 
Response:  Review of Recently Approved Drugs, Clin Pharmacol Ther, Mar;97(3):263273. 
20 See footnote 5. 
21 Improving the Collection and Use of Racial and Ethnic Data in HHS (December 1, 1999), available at 
https://aspe.hhs.gov/report/improving-collection-and-use-racial-and-ethnic-data-hhs. 
22 See footnote 7. 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
121  III.  COLLECTING RACE AND ETHNICITY DATA IN CLINICAL TRIALS AND 
122  CLINICAL STUDIES23 
123   
124  OMB Policy Directive 15 provides a minimum standard for maintaining, collecting, and 
125  presenting data on race and ethnicity for Federal reporting purposes.  As previously stated, the 
126  categories in this classification are social-political constructs and should not be interpreted as 
127  being scientific or anthropological in nature.  OMB recommends a two-question format to 
128  provide flexibility and ensure data quality for reporting race and ethnicity as described below.  
129   
130  A.  Two-Question Format 
131   
132  To remain consistent with OMB Policy Directive 15, FDA recommends using the two-question 
133  format for requesting race and ethnicity information, with the ethnicity question preceding the 
134  question about race.24  For example: 
135   
136  Question 1 (answer first):  Are you Hispanic/Latino or not Hispanic/Latino? 
137   
138  Question 2 (answer second):  What is your race?25  More than one choice is acceptable. 
139   
140  B.  Self-Reporting 
141   
142  Consistent with best practices, FDA recommends that trial participants self-report race and 
143  ethnicity information and that those individuals be permitted to designate a multiracial identity.  
144  When the collection of self-reported designations is not feasible (e.g., because of the 
145  participants inability to respond), FDA recommends requesting information from a first-degree 
146  relative or other knowledgeable representative.  Race and ethnicity should not be assigned by the 
147  study team conducting the trial.  While data on race and ethnicity may be available in a patients 
148  medical record, FDA recommends that investigators and/or other clinical study staff verify the 
149  accuracy of the information provided in the medical record with the study participant.  
150   
151  C.  Ethnicity 
152   
153  For ethnicity, we recommend the following minimum choices be offered: 
154   
155    Hispanic or Latino 
156   
157    Not Hispanic or Latino 
158   
 
23 FDA recognizes that the collection of race and ethnicity data in clinical practice may vary considerably and 
impact demographic data available for analysis in non-interventional studies.  Sponsors seeking to conduct non-
interventional studies to support regulatory decision-making should discuss the availability of race and ethnicity data 
with the relevant review division. 
24 For more information on the basic racial and ethnic categories for Federal statistics and program reporting, see 
OMB Policy Directive 15, described in footnote 5. 
25 Note:  Please see racial designations in section III.D of this guidance. 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
159  D.  Race 
160   
161  For race, we recommend the following minimum choices26 be offered: 
162   
163    American Indian or Alaska Native 
164   
165    Asian 
166   
167    Black or African American 
168   
169    Native Hawaiian or Other Pacific Islander 
170   
171    White 
172   
173  FDA recommends offering an option of selecting one or more racial designations or additional 
174  subgroup designations.  Recommended forms for the instruction accompanying the multiple 
175  response questions are Mark one or more and Select one or more. 
176   
177  Sponsors should report the number of respondents in each racial category who self-reported as 
178  Hispanic or Latino.  When aggregate data are presented, data producers should provide the 
179  number of respondents who marked (or selected) only one category, separately for each of the 
180  five racial categories.  In addition to these numbers, sponsors are encouraged to provide the 
181  detailed distributions, including all possible combinations of multiple responses to the race 
182  question.  If data on multiple responses are condensed, at a minimum the total number of 
183  respondents reporting more than one race should be reported.  
184   
185  E.  Use of More-Detailed Racial and Ethnic Categories 
186   
187  In certain situations, as recommended in OMB Policy Directive 15, more-detailed race and/or 
188  ethnicity information may be desired.  For example, for clinical trials enrolling participants 
189  outside the United States, FDA recognizes that the recommended categories for race and 
190  ethnicity were developed in the United States and that these categories may not adequately 
191  describe racial and ethnic groups in other countries.  
192   
193  Where appropriate, FDA recommends using more-detailed categories by geographic region to 
194  provide sponsors flexibility in characterizing race and ethnicity.  FDA recommends that these 
195  characterizations be aligned with the five minimum designations for race and the two 
196  designations for ethnicity listed previously in subsections D and C, respectively.  If additional 
197  granularity or more-detailed characterizations of race or ethnicity are collected to enhance 
198  understanding of the trial participants, FDA recommends following the 2011 HHS 
199  Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary 
200  Language, and Disability Status,27 as described below.     
 
26 As explained in the next section of this guidance (section III.E), sponsors may include more-detailed categories, 
and doing so is recommended where appropriate. 
27 See footnote 7. 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
201   Ethnicity Data Standard 
202  Are you Hispanic or Latino?  (One or more categories may be selected.) 
203   
204  a.    No, not Hispanic or Latino 
205  b.    Yes, Mexican, Mexican American, Chicano 
These categories are part of the 
206  c.    Yes, Puerto Rican 
Hispanic or Latino category of 
207  d.    Yes, Cuban 
the OMB standard 
208  e.    Yes, Other Hispanic or Latino  
209   
210  Race Data Standard 
211  What is your race?  (One or more categories may be selected.) 
212   
213  a.    White 
These categories are part of the 
214  b.    Black or African American 
OMB standard 
215  c.    American Indian or Alaska Native 
216  d.    Asian Indian 
217  e.    Chinese 
218  f.     Filipino 
These categories are part of the 
219  g.    Japanese 
Asian category of the OMB standard 
220  h.    Korean 
221  i.     Vietnamese 
222  j.     Other Asian 
223  k.    Native Hawaiian  These categories are part of the Native Hawaiian 
224  l.     Guamanian or Chamorro  or Other Pacific Islander category of the OMB 
225  m.     Samoan  standard 
226  n.    Other Pacific Islander 
227   
228  OMB Policy Directive 15 states that the term nonwhite is not acceptable for use in the 
229  presentation of Federal Government data.  It should not be used in publication or text of any 
230  report.  If there are questions or concerns regarding the collection of race or ethnicity categories, 
231  sponsors are encouraged to discuss the matter with the appropriate review division. 
232   
233   
234  IV.  PRESENTATION OF RACE AND ETHNICITY DATA IN CLINICAL TRIALS AND 
235  CLINICAL STUDIES 
236   
237  For INDs, NDAs, and BLAs, we recommend that the submission of demographic data for all 
238  new clinical trials and clinical studies be tabulated using the characterizations of race and 
239  ethnicity described in this guidance.  For medical device submissions, see also the guidance for 
240  industry Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical 
241  Device Clinical Studies (September 2017)  
242   
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
243  The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation 
244  and Research (CBER) require marketing applications to be submitted electronically.28  CDER 
245  and CBER use the electronic common technical document (eCTD) as the standard for their 
246  electronic applications.  When submitting an electronic application, presentation of demographic 
247  data is described in the ICH guidance for industry M4E(R2):  The CTD  Efficacy (July 2017), 
248  which suggests a tabular display of demographic characteristics, including race, by treatment 
249  group (e.g., active drug, placebo).29   
250   
251  FDA recommends that applicants include race and ethnicity information (using the categories 
252  described in section III of this guidance) in their proposed product labeling.  For example, the 
253  CLINICAL STUDIES section of drug and biological product labeling should include the 
254  baseline demographics (including racial and ethnic characteristics) of the studied population.30  
255  The ADVERSE REACTIONS section of drug and biological product labeling should include the 
256  baseline demographics of the safety population.31  If the baseline demographics in the safety and 
257  efficacy populations are generally the same and the description of the baseline demographics are 
258  included in the CLINICAL STUDIES section, instead of repeating the same baseline 
259  demographics in the ADVERSE REACTIONS section, the ADVERSE REACTIONS section 
260  can cross-reference the CLINICAL STUDIES section.  OMB Policy Directive 15 states that the 
261  term nonwhite is not acceptable for use in the presentation of Federal Government data.  It 
262  should not be used in publication or text of any report.  If there are questions or concerns 
263  regarding the collection of race or ethnicity categories, sponsors are encouraged to discuss the 
264  matter with the appropriate review division.32   
265   
 
28 See the guidance for industry Providing Regulatory Submissions in Electronic Format  Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (February 2020). 
29 See the revision of M4E Guideline on Enhancing the Format and Structure of Benefit-Risk Information in the 
International Council for Harmonisation (ICH) guidance for industry M4E(R2):  The CTD  Efficacy (July 2017).  
30 See section III.B.4 in the guidance for industry Clinical Studies Section of Labeling for Human Prescription Drug 
and Biological Products  Content and Format (January 2006). 
31 See the guidance for industry Adverse Reactions Section of Labeling for Human Prescription Drug and Biological 
Products  Content and Format (January 2006). 
32 See section III.E of this guidance. 
  8