Pharmacogenomic Data 
Submissions 
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DRAFT GUIDANCE
 
 
  This guidance document is being distributed for comment purposes only.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 ___ 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of publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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_OCP_GPT@fda.hhs.gov. 
 
 
 
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) 
National Center for Toxicological Research 
(NCTR) 
 
March 2023 
Procedural 
OMB Control Number 0910-0557 
Draft Guidance Temp 
03/16/23   
Pharmacogenomic Data 
Submissions 
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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm    
 
 
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) 
National Center for Toxicological Research 
(NCTR) 
 
 
 
 
 
 
 
March 2023 
Procedural 
OMB Control Number 0910-0557 
Draft Guidance Temp 
03/16/23  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  SUBMISSION POLICY ................................................................................................... 2 
A.  Submission of Pharmacogenomic Data Under IND Regulations ...........................................4 
B.  Submission of Pharmacogenomic Reports and Data Under NDA and BLA Regulations.......7 
IV.  FORMAT AND CONTENT OF SUBMISSIONS ......................................................... 8 
A.  Reports .................................................................................................................................8 
B.  Subject-Level Data Submissions ...........................................................................................9 
C.  Location .............................................................................................................................. 10 
Draft Guidance Temp 
03/16/23  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Pharmacogenomic Data Submissions 
2  Guidance for Industry1 
3   
4   
5  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
6  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
7  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
8  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
9  for this guidance as listed on the title page.   
10   
11   
12   
13   
14  I.  INTRODUCTION  
15   
16  This guidance is intended to facilitate progress in the field of pharmacogenomics and the use of 
17  pharmacogenomic data in drug2 development. This document is intended to clarify the contexts 
18  in which pharmacogenomic study findings and data must be included in submissions related to 
19  investigational new drug applications (INDs), new drug applications (NDAs), and biologics 
20  license applications (BLAs) based on the FDAs regulations. In addition, this document provides 
21  recommendations to sponsors and applicants on the format and content of the pharmacogenomic 
22  data submissions. 
23   
24  For the purposes of this guidance, the term pharmacogenomics is defined as the study of 
25  variations of DNA and RNA characteristics as related to drug response;3 DNA or RNA 
26  variations can be germline, somatic, or microbial. Pharmacogenomics does not refer to data 
27  resulting from proteomic, metabolomic, or other -omic studies, although similar considerations in 
28  this guidance could be applicable for determining whether to submit findings and data from such 
29  studies. 
30   
31  In 2005, FDA issued a final guidance for industry, Pharmacogenomic Data Submissions. When 
32  finalized, this guidance will replace the 2005 guidance.  
33   
34  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
35  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
 
1 This guidance has been prepared by the Office of Clinical Pharmacology in the Center for Drug Evaluation and 
Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug 
Administration as well as the National Center for Toxicological Research.  
 
2 For the purposes of this guidance, the terms drug product or drug will be used to refer to human prescription drug 
and biological products that are regulated as drugs. 
 
3 For more information, see the FDA guidance entitled E15: Definitions for Genomic Biomarkers, 
Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (April 2008). 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.  
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36  as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
37  the word should in Agency guidances means that something is suggested or recommended, but 
38  not required.  
39   
40   
41  II.  BACKGROUND 
42   
43  Pharmacogenomic studies have the potential to help identify sources of interindividual 
44  variability in drug exposure or response (both effectiveness and toxicity), making it possible to 
45  optimize therapy for individuals. Currently, several pharmacogenomic biomarkers with well-
46  accepted mechanistic and clinical significance are being integrated into drug development (e.g., 
47  enriched clinical trial designs) and clinical practice.  
48   
49  Sponsors and applicants submitting or holding INDs, NDAs, or BLAs are subject to FDA 
50  requirements for submitting data to the FDA that are relevant to drug safety and effectiveness.4  
51  However, the regulations were developed before the advent of widespread animal or human 
52  genetic testing (e.g., high-throughput DNA sequencing) or gene expression testing and do not 
53  specifically describe the submission requirements for such data as a separate category.5   
54   
55  This guidance, when final, will constitute the FDA's current thinking about pharmacogenomic 
56  study results and the associated data required to be submitted in IND, NDA, or BLA 
57  submissions, as well as the FDAs recommendations as to the level of detail and format for 
58  reporting. Discussions of when and how to submit pharmacogenomic study results and the 
59  associated data in an investigational device exemption (IDE) application or other device 
60  submission to the FDA are excluded from the scope of this document.6 This guidance is intended 
61  to facilitate the generation and use of pharmacogenomic data during drug development. The 
62  policies outlined in this guidance are intended to advance the field in a manner that will benefit 
63  both drug development programs and public health.  
64   
65   
66  III.  SUBMISSION POLICY    
67   
68  The FDAs regulations establish requirements for the submission of information in INDs, NDAs, 
69  and BLAs.7 Consistent with these regulations, the sections below summarize the contexts in 
70  which pharmacogenomic study results and data must be reported in IND, NDA, and BLA 
71  submissions.8    
 
4 21 CFR parts 312, 314, and 601 (including 21 CFR 312.22, 312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 
601.12). 
 
5 21 CFR parts 312, 314, and 601. 
 
6 21 CFR part 812. 
 
7 21 CFR parts 312, 314, and 601. 
 
8 21 CFR parts 312, 314, and 601 (including 21 CFR 312.22, 312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 
601.12). 
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72   
73  Table 1 also summarizes the FDAs recommendations on the amount and level of detail to report 
74  for each context in which pharmacogenomic study results and data are reported to the FDA. The 
75  amount and level of detail to report to the FDA should vary depending on the context of how the 
76  genomic biomarkers are utilized and the potential risks associated with the biomarker. For 
77  example, data related to exploratory safety studies should be supplied in a brief synopsis, 
78  whereas data supporting statements in FDA labeling should be supplied in submission of subject-
79  level data from clinical trials. Genomic data that fit multiple contexts should be submitted at the 
80  more detailed reporting level. For example, genomic biomarker studies that are related to 
81  pharmacokinetics (e.g., drug metabolizing enzyme gene variants) are recommended to be 
82  submitted as a synopsis. However, if those same genomic data are also the basis for patient 
83  dosing, subject-level data, and a full report rather than only a synopsis should be submitted. 
84  More detailed reports and data can be submitted where synopses are recommended. Furthermore, 
85  the FDA may request additional data (e.g., detailed reports, subject level data) as needed for the 
86  review of IND submissions as well as NDAs or BLAs as outlined in 21 CFR parts 312, 314, and 
87  601.   
88   
89  Sections III.A and III.B provide additional information regarding the submission of 
90  pharmacogenomic data under IND regulations and NDA and BLA regulations, respectively. For 
91  additional information on data submission and report formats, see section IV. 
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Table 1. Contexts for When Pharmacogenomic Data Submissions Are Required and 
Recommended Reporting Levels 
Context of Genomic Biomarker Study  Reporting Level 
Results ( 312.23, 312.32, 312.33, 314.50,  IND  NDA/BLA 
314.81, 601.2, 601.12)     
 
Proposed for inclusion in labeling 
Detailed Report, 
  -- 
Subject-Level Data 
 
Justifies the use of a genomic biomarker in the 
design, conduct, or analysis of planned clinical 
Detailed Report  -- 
trials intended to support approval* 
 
Results from the integral use of a genomic 
biomarker in the design, conduct, or analysis of  Detailed Report, 
Synopsis 
completed clinical trials*  Subject-Level Data 
 
Indicates substantial differences in responses 
related to efficacy across subgroups  Synopsis  Detailed Report 
 
Indicates a significant risk in a subset of 
individuals   Synopsis  Detailed Report 
 
Relates to pharmacokinetics (i.e., drug 
metabolism or transport)  Synopsis  Synopsis 
 
Relates directly to the drugs target or 
mechanism of action or informs 
Synopsis  Synopsis 
pharmacodynamic effects 
 
Relates to safety but does not indicate a 
significant risk or a potential safety issue  --  Synopsis 
 
 
* In effect, the genomic biomarker is used for the inclusion or exclusion of study subjects, treatment allocation 
(e.g., stratified randomization), subgroup hypothesis testing, or altered dosing or monitoring.  
 
 For example, a genetic marker reaches genome-wide significance in a genome-wide association study for a 
response related to efficacy or a significant risk, whether based on the analysis of an individual study or multiple 
studies. 
 
92   
93  A.  Submission of Pharmacogenomic Data Under IND Regulations 
94   
95    21 CFR part 312 describes reporting requirements for IND sponsors. Sponsors are 
96  required to submit certain information related to an IND for which they are responsible in 
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97  order to comply with the regulations requirements.9 The contexts in which 
98  pharmacogenomic data must be submitted and the FDAs recommendations for the extent 
99  of and mechanism for reporting are as follows: 
100   
101    Pharmacogenomic study findings supporting the use of a genomic biomarker in 
o
102  the design, conduct, or analysis10 of planned clinical trials are required to be 
103  reported to the FDA with detailed information about such findings.11 Detailed 
104  reports should be submitted in this context to facilitate the review of the 
105  biomarkers clinical validity and ensure that trials making use of the biomarker 
106  are expected to meet stated objectives.12 Detailed reports should be submitted in 
107  the IND under the Previous Human Experience section, in meeting packages, or 
108  in clinical study protocols/reports, as appropriate.    
109   
110    Pharmacogenomic study results from completed clinical trials where the 
o
111  biomarker was integral to the design, conduct, or analysis [are] pertinent to the 
112  understanding of the drugs actions and must be described in Annual Reports.13   
113   
114    Pharmacogenomic study findings derived from animal or in vitro studies must be 
o
115  submitted when intended primarily to support the safety of the proposed clinical 
116  investigation.14 
117   
118    The FDA recognizes that many pharmacogenomic studies are exploratory and 
o
119  might not have been replicated. However, pharmacogenomic studies that identify 
120  significant predictors of treatment response must be reported in Annual Reports 
121  because they pertain to understanding the drugs actions.15 Significant predictors 
122  of treatment response include substantial differences in treatment response across 
123  biomarker-defined subgroups or statistically significant relationships between the 
124  biomarker and primary study endpoints in the context of the study. In addition, all 
125  pharmacogenomic studies generating data related to the effect of variation in the 
126  drug target or other genes related to the mechanism of action on efficacy or safety 
127  endpoints, as well as pharmacodynamic studies that make use of genomic 
128  biomarkers as an endpoint (e.g., gene expression), must also be reported in 
 
9 See 312.23, 312.32, 312.33. 
 
10 In effect, the genomic biomarker is used for the inclusion or exclusion of study subjects, treatment allocation (e.g., 
stratified randomization), subgroup hypothesis testing, altered dosing, or monitoring. 
 
11 21 CFR 312.23(a)(9)(i).  
 
12 21 CFR 312.23(a)(9)(i) for information on the detailed information that must be submitted to the FDA. 
 
13 21 CFR 312.33(b)(5). 
 
14 21 CFR 312.23(a)(8)(ii). 
 
15 21 CFR 312.33(b)(5). 
 
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129  Annual Reports because they pertain to understanding the drugs actions.16 These 
130  pharmacogenomic studies should be reported as synopses and should also be 
131  included in meeting packages and/or in clinical study protocols/reports, as 
132  appropriate. A study could be an analysis of an individual study or a pooled 
133  analysis of multiple trials. Statistical significance should be considered in the 
134  context of applying conventional multiplicity corrections.    
135   
136    Pharmacogenomic study findings related to safety endpoints must be reported in 
o
137  IND Safety Reports because they pertain to the drugs safety17 or in Annual 
138  Reports because they pertain to understanding the drugs actions.18 These 
139  pharmacogenomic studies should be reported as synopses and should also be 
140  included in meeting packages and/or in clinical study protocols/reports, as 
141  appropriate. Pharmacogenomic findings that identify predictors of adverse events 
142  which may pose significant risks to study subjects, or otherwise indicate a 
143  significant risk, must be submitted in an IND Safety Report.19   
144   
145    Other studies related to safety endpoints or that use gene expression as an 
o
146  endpoint to identify safety signals but do not identify any significant relationships 
147  must be described in Annual Reports.20 Pertinent negative findings must be 
148  explicitly reported (e.g., absence of HLA involvement in immune-related adverse 
149  events, or absence ADME-related effects where an exposure-response 
150  relationship for safety has been documented).21  
151   
152    Study findings related to pharmacokinetics must be reported in Annual Reports 
o
153  because they pertain to the drugs bioavailability and/or dose-response 
154  relationship.22 This can include pharmacokinetic studies where enrollment is 
155  prospectively based on drug metabolizing enzyme or transporter genotype, or 
156  retrospective studies on efficacy, safety, or pharmacokinetic endpoints (e.g., drug 
157  metabolizing enzyme and transporter panels). These studies should be reported as 
158  synopses and should also be included in meeting packages and/or in clinical study 
159  protocols/reports, as appropriate. 
160   
161    FDA regulations require inclusion of a summary of relevant data related to 
 
16 21 CFR 312.33(b)(5). 
 
17 21 CFR 312.32(c)(1)(ii). 
 
18 21 CFR 312.33(b)(5). 
 
19 21 CFR 312.32(c)(1)(ii).   
 
20 21 CFR 312.33(b)(5). 
 
21 21 CFR 312.33(b)(5). 
 
22 21 CFR 312.33(b)(5). 
 
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162  pharmacogenomic associations with pharmacokinetics, effectiveness, or safety in 
163  Investigator Brochures.23 
164   
165    Pharmacogenomic studies that are not required to be submitted under 21 CFR part 312 
166  can be voluntarily reported. 
167   
168    21 CFR 312.23(a)(11) states that a sponsor shall submit "[i]f requested by FDA, any 
169  other relevant information needed for review of the application." Therefore, during the 
170  IND review, the FDA might request additional pharmacogenomic information it 
171  considers relevant. 
172   
173  B.  Submission of Pharmacogenomic Reports and Data Under NDA and BLA 
174  Regulations 
175   
176    21 CFR 314.50 outlines the NDA submission requirements. As the introduction to 21 
177  CFR 314.50 states, [t]he NDA is required to contain reports of all investigations of the 
178  drug product sponsored by the applicant, and all other information about the drug 
179  pertinent to an evaluation of the NDA that is received or otherwise obtained by the 
180  applicant from any source. Information that is pertinent to an evaluation of the 
181  application includes information related to each controlled clinical study pertinent to a 
182  proposed use of the drug, a description and analysis of any other data or information 
183  relevant to an evaluation of the safety and effectiveness of the drug product, and [a] 
184  summary and updates of safety information.24 The pharmacogenomic studies required to 
185  be submitted to the FDA for an IND are generally relevant to the FDAs evaluation of the 
186  safety and effectiveness of a drug product. Therefore, to comply with these regulations, 
187  sponsors must provide reports of certain pharmacogenomic studies in their NDAs as 
188  outlined in Table 1.25 Table 1 also specifies the recommended reporting level for each 
189  type of pharmacogenomic study reported in NDAs. Sponsors can discuss submission of 
190  pharmacogenomic reports and data in NDA submissions at pre-NDA meetings. 
191   
192    21 CFR 601.2 generally outlines the BLA submission requirements. 21 CFR 601.2 states 
193  that the BLA manufacturer shall submit data derived from nonclinical laboratory and 
194  clinical studies which demonstrate that the manufactured product meets prescribed 
195  requirements of safety, purity, and potency... The pharmacogenomic studies required to 
196  be submitted to the FDA for an IND are generally relevant to the FDAs evaluation of the 
197  safety, purity, and potency of a biological product. Therefore, like NDA sponsors, BLA 
198  sponsors must provide reports of certain pharmacogenomic studies in their BLAs as 
199  outlined in Table 1.26 Table 1 also specifies the recommended reporting level for each 
 
23 21 CFR 312.23(a)(5)(iii) and 21 CFR 312.23(a)(5)(iv). 
 
24 21 CFR 314.50(d)(5)(iv) and (vi); 21 CFR 314.50(d)(5)(vi) also identifies the specific types of information that 
constitute the summary and updates of safety information. 
 
25 21 CFR 312 and 314. 
 
26 21 CFR 312 and 601. 
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200  type of pharmacogenomic study reported in BLAs. Sponsors can discuss submission of 
201  pharmacogenomic reports and data in BLA submissions at pre-BLA meetings. 
202   
203    In addition, if a sponsor intends for pharmacogenomic study data to be used in the drug 
204  labeling or as part of the scientific database being relied upon to support approval, then 
205  data must be submitted from such studies to the NDA or BLA.27 Such data should be 
206  submitted as subject-level data in a detailed report. This includes data pertaining to 
207  pharmacogenomic biomarkers that inform labeling, because the data pertain to selecting 
208  patients for clinical trials (whether enrollment is limited to or stratified by the 
209  biomarkers), determining dosing and administration, or informing drug-drug interactions 
210  (or lack thereof). Also, information not tied to specific clinical recommendations must be 
211  submitted if it relates to any narrative about the drugs pharmacokinetic disposition or 
212  clinical trial populations in labeling.28  
213   
214    21 CFR 314.81(b)(2) and 601.12 outline the requirements for submitting to a previously 
215  approved NDA or BLA, new scientific information that might affect the safety, 
216  effectiveness, or labeling of a drug. Pharmacogenomic studies outlined in Table 1, and as 
217  further described in section III.A, must be submitted in Annual Reports29 and should also 
218  be submitted, as appropriate, in meeting packages and/or clinical study protocols/reports.  
219   
220    Pharmacogenomic studies that are exploratory in nature, such as initial studies to 
221  discover predictors of drug response, pharmacoepidemiologic, or observational studies, 
222  and that are not described in Table 1 or sections III.A or III.B, are not required to be 
223  reported. 
224   
225   
226  IV.  FORMAT AND CONTENT OF SUBMISSIONS 
227   
228  A.  Reports 
229   
230  The FDA recommends that synopses of pharmacogenomic studies should include a brief 
231  summary of the following: 
232   
233    Study design, and if a substudy, a description of the clinical studies from which 
234  specimens for genomic analyses were acquired  
235   
236    Methods, including assay method/platform and patient inclusion/exclusion criteria 
237   
238    Statistical analysis plan, including prespecified endpoints, the analysis population, 
239  multiplicity corrections, and models utilized 
240   
 
27 21 CFR 314.50(c)(2)(i), 314.50(d)(5)(ii), (iv), (v), and (vi), and 601.2. 
 
28 21 CFR 314.50(c)(2)(i), 314.50(d)(5)(ii), (iv), and (v), and 601.2. 
 
29 21 CFR 314.81(b)(2) and 601.12. 
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241    Topline results, including sample size and findings that meet study-level significance or 
242  for key prespecified endpoints  
243   
244  The FDA recommends that detailed reports of pharmacogenomic studies include the following: 
245   
246    Synopsis 
247   
248    Introduction, including the rationale for the study 
249   
250    Objectives, including the objectives and prespecified endpoints of both the 
251  pharmacogenomic study and, if a substudy, the clinical studies from which specimens for 
252  genomic analyses were acquired 
253   
254    Methods 
255   
256    Clinical trial/study methods, including study design, treatment regimens, 
o
257  inclusion/exclusion criteria for the primary study and substudy (as applicable),  
258  key prespecified endpoints 
259   
260    Genetic study methods, including study designs, data-generation platform, 
o
261  specific allele selection, sample handling and isolation, assay quality control, 
262  genotype/phenotype relationships, source and version of genomic references, and 
263  databases utilized 
264   
265    Statistical methods, including model or algorithm for analyses, the prespecified 
o
266  analysis population, corrections for multiplicity, tools, versions, and parameters 
267  used at each stage of the analyses, adjustments for race/ethnicity, computational 
268  environment and resources used to process data, and handling of missing data30 
269   
270    Results, including demographics of the overall and genotyped populations, 
271  genotype/haplotype distributions, association results, appropriate graphical or table-based 
272  summaries (e.g., box plots, Kaplan-Meier plots) 
273   
274    Discussion and Conclusions 
275   
276    Pharmacogenomic study reports, submitted using the pharmacogenomics file-tag in 
277  eCTD backbone files and study tagging files, as appropriate 
278    
279  B.  Subject-Level Data Submissions 
280   
281    Study data contained in NDAs, certain BLAs, and certain INDs must be in an electronic 
282  format that the Agency can process, review, and archive, unless such submission is 
 
30 For more information on the FDAs expectations for and recommendations on use of a standardized approach for 
collecting and reporting race and ethnicity data in submissions for clinical trials, see the FDA guidance entitled 
Collection of Race and Ethnicity Data in Clinical Trials (October 2016). 
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283  exempt from the electronic submission requirements, or if the FDA has granted a 
284  waiver.31 For more information on electronic submissions, please see Providing 
285  Regulatory Submissions in Electronic Format - Standardized Study Data, Providing 
286  Regulatory Submissions in Electronic Format - IND Safety Reports, and the Study Data 
287  Technical Conformance Guide.32   
288   
289    Relevant data obtained from high-throughput analysis platforms can be extracted at the 
290  sponsors discretion. If such data are contained in NDAs, certain BLAs, and certain 
291  INDs, the data must be in an electronic format that the Agency can process, review, and 
292  archive, unless such submission is exempt from the electronic submission requirements, 
293  or if the FDA has granted a waiver.33  
294   
295    If pharmacogenomic study data are not able to be linked to primary clinical trial datasets 
296  based on the informed consent (e.g., genetic data are anonymized), relevant clinical trial 
297  data should be included in separate analysis datasets.   
298   
299  C.  Location34 
300   
301    Synopses and detailed reports submitted to the IND should be referenced in relevant 
302  sections of a submission, such as Safety Reports or in Annual Reports, as appropriate.  
303  The FDA also encourages reporting of these results in meeting packages, clinical study 
304  reports, or other submissions to the FDA, as appropriate. 
305   
306    Synopses or detailed reports and associated data submitted to NDAs or BLAs should be 
307  referenced in relevant sections of a submission. Analyses for a single study should be 
308  incorporated within the clinical study reports and clinical trial datasets for that single 
309  study; analyses and datasets from multiple studies should be submitted as a separate 
310  report under Reports of analyses of data from more than one study, section 5.3.5.3 of the 
311  eCTD. The FDA encourages summarizing these data in relevant submission summaries 
312  such as the Integrated Summary of Safety or the Integrated Summary of Effectiveness, as 
313  appropriate. 
 
31 Section 745A(a) of the FD&C Act.  
 
32 Available at http://www.fda.gov/eStudyResources. 
 
33 Section 745A(a) of the FD&C Act. 
 
34 The eCTD Submission Standards, which include a Comprehensive Table of Contents of Headings and Hierarchy 
and eCTD Specifications, can be found at the following link: https://www.fda.gov/drugs/electronic-regulatory-
submission-and-review/electronic-common-technical-document-ectd. Detailed reports of pharmacogenomic studies 
should be reported using the pharmacogenomics file-tag.  
10