Electronic Submission 
of Expedited Safety 
Reports From  
IND-Exempt  
BA/BE Studies 
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DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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) Susan Levine 240-402-7936  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
August 2022 
Generic Drugs 
 
   
Electronic Submission 
of Expedited Safety 
Reports From  
IND-Exempt  
BA/BE Studies  
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  
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
 
 August 2022 
Generic Drugs 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 1 
III.  ELECTRONIC SUBMISSION OF EXPEDITED SERIOUS ADVERSE EVENT 
REPORTS FROM IND-EXEMPT BA/BE STUDIES .................................................. 3 
A.  Methods for Electronic ICSR Submission ................................................................................... 4 
B.  Identification of the ICSRs ............................................................................................................ 5 
C.  ICSR Attachments ......................................................................................................................... 5 
D.  Initial and Follow-Up ICSRs ......................................................................................................... 6 
E.  Product Names for Study Drugs ................................................................................................... 6 
F.  Description of Drug Exposure ...................................................................................................... 7 
G.  Notification of Receipt of Electronic ICSR Submission by the FDA ......................................... 8 
H.  Additional Supportive Resources ................................................................................................. 8 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Electronic Submission of Expedited Safety Reports From  
2  IND-Exempt BA/BE Studies  
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 and is not 
8  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
9  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
10  for this guidance as listed on the title page.   
11   
12   
13   
14   
15  I.  INTRODUCTION  
16   
17  This guidance provides instructions for the electronic submission of expedited individual case 
18  safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability 
19  (BA)/bioequivalence (BE) studies2 through the FDA Adverse Event Reporting System (FAERS) 
20  database.  An ICSR captures information necessary to support the reporting of an adverse event 
21  related to an individual subject that is associated with the use of an FDA-regulated product.3 The 
22  electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for 
23  submission.   
24   
25  The contents of this document do not have the force and effect of law and are not meant to bind 
26  the public in any way, unless specifically incorporated into a contract. This document is intended 
27  only to provide clarity to the public regarding existing requirements under the law. FDA 
28  guidance documents, including this guidance, should be viewed only as recommendations, unless 
29  specific regulatory or statutory requirements are cited. The use of the word should in FDA 
30  guidance means that something is suggested or recommended, but not required. 
31   
32   
33  II.  BACKGROUND 
34   
 
1 This guidance has been prepared by the Office of Generic Drugs in the Center for Drug Evaluation and Research at 
the Food and Drug Administration.  
 
2 BA and BE studies that meet the conditions for exemption under 21 CFR 320.31 are not conducted under an IND 
and are not subject to the IND safety reporting requirements.  The safety reporting requirements under  
320.31(d)(3) apply to persons conducting BA or BE studies that are exempt from the IND requirements. 
 
3 See additional information on the Individual Case Safety Reports web page, available at 
https://www.fda.gov/industry/fda-resources-data-standards/individual-case-safety-reports. 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
35  In the Federal Register of September 29, 2010,4 FDA published a final rule that revised the IND 
36  (including Bio-IND)5 safety reporting requirements for human drug and biological products under 
37  21 CFR part 312.6 It added safety reporting requirements for persons conducting IND-exempt 
38  BA/BE studies under 21 CFR 320.31.7 This regulation outlines when BA and BE studies are 
39  exempt from the IND requirements.8  The exemption from IND requirements may apply to 
40  studies conducted to support abbreviated new drug applications (ANDAs) and other drug 
41  applications.   
42   
43  A safety report documenting a serious adverse event (SAE)9 experienced by a study subject 
44  during conduct of an IND-exempt BA/BE study must be submitted on Form FDA 3500A or in an 
45  electronic format that FDA can process, review, and archive.10  As required by regulation, a 
46  safety report documenting a fatal or life-threatening adverse event from the study must be 
47  submitted to FDA as soon as possible but in no case later than 7 calendar days after becoming 
48  aware of its occurrence (7-day report).11  Safety reports documenting other SAEs observed 
49  during the conduct of the study must be submitted to FDA as soon as possible but no later than 
 
4 Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety 
Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans (75 FR 59935, September 29, 
2010).  
 
5 See  320.31(a) through (b) that describes when any person conducting an in vivo BA or BE study must submit an 
IND.  The term Bio-IND refers to such an IND.  MAPP 5210.5 Rev. 3 Review of Investigational New Drug 
Applications (Bio-INDs) by the Office of Generic Drugs (April 14, 2022). 
 
6 For Bio-INDs, the IND safety reporting requirements under 21 CFR 312.32(c)(1)(i) apply.   
 
7 For additional information on meeting safety reporting requirements for Bio-IND or IND-exempt BA/BE studies, 
see the following documents: the guidance for industry Safety Reporting Requirements for INDs and BA/BE Studies 
(December 2012), (see also the draft guidance for industry Sponsor Responsibilities - Safety Reporting Requirements 
and Safety Assessment for IND and Bioavailability/Bioequivalence Studies (June 2021), which when final, will 
represent the FDAs current thinking on this topic and includes recommendations to help the companies conducting 
IND-exempt BA/BA studies comply with reporting requirements); the draft guidance for industry Providing 
Regulatory Submissions in Electronic Format: IND Safety Reports (October 2019) ,which when final, will represent 
the FDAs current thinking on this topic; and the guidance for industry, Electronic Submission of IND Safety 
Reports Technical Conformance Guide (April 2022). 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.  FDAs Study Data Standards Resources are available at https://www.fda.gov/industry/fda-
resources-data-standards/study-data-standards-resources. 
 
8  320.31(d).   
 
9 Serious adverse event (SAE) is defined at  312.32(a).  An adverse event is considered serious if, in the view of 
either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or 
substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.  Important 
medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious 
when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require 
medical or surgical intervention to prevent one of the outcomes listed in this definition. 
 
10  320.31(d)(3). 
 
11 Id. 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
50  15 calendar days after becoming aware of the SAE occurrence (15-day report).12  The expedited 
51  reporting requirements for IND-exempt BA/BE studies apply only to BA/BE studies conducted 
52  in the United States.   
53   
54  In addition to the requirements for expedited safety reporting described in  320.31(d), as part of 
55  the information required to establish that the drug product can be expected to have the same 
56  therapeutic effect as the listed product, adverse events information from IND-exempt BA/BE 
57  studies, regardless of whether the study is conducted inside or outside of the United States, must 
58  be included in an ANDA or NDA submission, as appropriate based on the purpose of the BA/BE 
59  study.13  
60   
61  In the past, expedited safety reports from IND-exempt BA/BE studies have been submitted to the 
62  Office of Generic Drugs (OGD) by email, telephone, or facsimile using the Form FDA 3500A.  
63  However, enhancements to FAERS will allow electronic submission of ICSRs from IND-exempt 
64  BA/BE studies.  This guidance provides recommendations on how to electronically submit 
65  ICSRs14 to the FAERS database as an alternate avenue for submitting reports to OGD once these 
66  enhancements are activated.15     
67   
68   
69  III.  ELECTRONIC SUBMISSION OF EXPEDITED SERIOUS ADVERSE EVENT 
70  REPORTS FROM IND-EXEMPT BA/BE STUDIES 
71   
72  ICSRs are used by investigators, pharmaceutical companies, institutional review boards, ethics 
73  committees, contract research organizations, etc., to perform pharmacovigilance monitoring 
74  activities and to communicate information about these adverse events to FDA and other 
75  regulatory bodies.  The International Council for Harmonisation of Technical Requirements for 
76  Pharmaceuticals for Human Use (ICH) E2B data standards working group developed common 
 
 
12 Id. 
 
13 See 21 CFR 314.94(a)(7) and 21 CFR 314.50(d)(5)(iv). As FDA explained in the 2010 final rule on 
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety 
Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans (see 75 FR at 59954) in 
response to comments about submitting SAEs that occurred during conduct of studies outside of the United States, 
as part of the information required to establish that the proposed drug product can be expected to have the same 
therapeutic effect as the reference listed product, adverse event reports that occurred in foreign clinical studies must 
be included in the ANDA submission . . . See guidance for industry Safety Reporting Requirements for INDs and 
BA/BE Studies (December 2012), (see also draft guidance for industry Sponsor Responsibilities - Safety Reporting 
Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies (June 2021)). 
 
14  320.31(d)(3). 
 
15 See the website FDA Adverse Event Reporting System (FAERS) Electronic Submissions, 
https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-
reporting-system-faers-electronic-submissions, for updates on the FAERS enhancements. 
 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
77  data elements for the electronic transmission of ICSRs globally among relevant stakeholders.16  
78  FDA also developed regional data elements for reporting on drug-device combination products 
79  and premarket (IND and BA/BE study) safety reports for drug products and some biological 
80  products.17 
81   
82  A.  Methods for Electronic ICSR Submission 
83   
84  FDA provides two options for electronic submission of ICSRs and ICSR attachments to the 
85  FAERS database:  
86   
87  (1) ICSR Option A: Database-to-Database Transmission (E2B)  
88    Submitters who have database-to-database transmission capability may directly 
89  submit ICSRs in the XML format18 via the Electronic Submissions Gateway (ESG). 
90  The ESG is a central transmission point for sending information electronically to 
91  FDA.19  Once received through the ESG, the submitted ICSRs are processed into the 
92  FAERS database.   
93    The direct electronic submission of ICSRs and ICSR attachments through the ESG is 
94  described on the FDA FAERS Electronic Submissions web page.20  Submitters 
95  should reference FDAs technical specifications document FDA Regional 
96  Implementation Guide for E2B(R3) Electronic Transmission of Individual Case 
97  Safety Reports for Drug and Biological Products for instructions on organizing, 
98  preparing, and submitting ICSR and ICSR attachments using the direct submission 
99  method through the ESG. 
100   
101  (2) ICSR Option B: Safety Reporting Portal (SRP) 
102    Submitters who do not have database-to-database transmission capability may submit 
103  electronic ICSRs using the SRP. Submitters can enter the ICSR information manually 
 
16 See E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files, available at  
https://www.ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-files.  
 
17 See the technical specifications document FDA Regional Implementation Guide for E2B(R3) Electronic 
Transmission of Individual Case Safety Reports for Drug and Biological Products (April 2022). For the most recent 
version of the technical specifications document, check the FAERS Electronic Submissions web page at 
https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-
reporting-system-faers-electronic-submissions. 
 
18 For additional instruction on how to begin submitting ICSRs in the XML format, check the Steps to Submitting 
ICSRs Electronically in the XML Format link, available at https://www.fda.gov/drugs/questions-and-answers-fdas-
adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions. 
 
19 See FDAs Electronic Submissions Gateway web page, available at https://www.fda.gov/industry/electronic-
submissions-gateway. 
 
20 See the Questions and Answers on FDA's Adverse Event Reporting System (FAERS) web page 
at   
https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers.  
 
 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
104  into a web-based form in the SRP, and this information is then submitted to FDA to 
105  be uploaded into the FAERS database.  
106    Submitters who are Gateway partners cannot use the SRP.  Gateway partners are 
107  those that submit ICSRs electronically via the ESG.  For information on how to 
108  submit ICSRs and ICSR attachments through the SRP, refer to the FDAs SRP web 
109  page.21 
110   
111  Both routes of submission are available 24 hours a day, 7 days a week.  To submit ICSRs 
112  electronically, either through the E2B or SRP, each submitter needs to have an account with 
113  FDA.  A separate account is needed for each option.  To create an account, submitters should 
114  notify the FAERS electronic submissions coordinator at faersesub@fda.hhs.gov.  The FAERS 
115  electronic submissions coordinator will assist submitters to help ensure that all steps are 
116  completed for successful submission of ICSRs and ICSR attachments. 
117   
118  B.  Identification of the ICSRs 
119   
120  FDA has established business rules to distinguish premarket ICSRs from postmarket ICSRs.22 
121  These rules enable identification and rejection of premarket ICSRs that are incorrectly submitted 
122  to the postmarket pathway in FAERS.  See the technical specifications document FDA Regional 
123  Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports 
124  for Drug and Biological Products for additional details on these business rules.  
125   
126  To voluntarily submit a premarket IND-exempt BA/BE ICSR in E2B data standard, submitters 
127  should use the E2B data element FDA.C.5.5b titled Pre-ANDA Number where serious AE 
128  Occurred to provide a valid pre-assigned ANDA (referred to as a Pre-ANDA) number in an 
129  appropriate format (123456). 23, 24, 25, 26 
130   
131  C.  ICSR Attachments 
132   
 
21 Available at https://www.safetyreporting.hhs.gov/SRP2.  
 
22 See the technical specifications document FDA Regional Implementation Guide for E2B(R3) Electronic 
Transmission of Individual Case Safety Reports for Drug and Biological Products. 
 
23 For information on requesting a pre-assigned ANDA number, see https://www.fda.gov/drugs/electronic-
regulatory-submission-and-review/requesting-pre-assigned-application-number.  
 
24 Although these are pre-assigned ANDA numbers and the term Pre-ANDA is used with these numbers, these 
submissions may or may not be associated with OGDs Pre-ANDA program for complex drug products.  See 
https://www.fda.gov/drugs/generic-drugs/pre-anda-program. 
 
25 See the technical specifications document FDA Regional Implementation Guide for E2B(R3) Electronic 
Transmission of Individual Case Safety Reports for Drug and Biological Products. 
 
26 See FDA E2B(R3) Core and Regional Data Elements and Business Rules. For the most recent version of this 
document, check the FAERS Electronic Submissions web page at https://www.fda.gov/drugs/questions-and-
answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-
submissions.  
 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
133  Attachments to ICSRs provide important supporting information and may include (but are not 
134  limited to): study protocols, case report forms (including assessments and test results), relevant 
135  medical records, and/or autopsy reports. Attachments can also be used for narrative  portions 
136  of the ICSR that exceed character limitation for that E2B data field; however, FDA encourages 
137  providing informative narratives that fit within the character limitations. The ICSR attachment 
138  can be sent at the same time as the ICSR submission either through the ESG27 or SRP28 route. 
139   
140  D.  Initial and Follow-Up ICSRs 
141   
142  Each ICSR should have a unique case identification number created by the submitter of the 
143  report that is the same for the initial report and all subsequent follow-up reports.  Follow-up 
144  ICSRs should include new information in the E2B data fields along with information previously 
145  reported in prior ICSR submissions for the SAE.  To avoid duplication, ICSR attachments 
146  submitted with an initial ICSR should not be resubmitted with a follow-up ICSR.  Follow-up 
147  ICSRs should be submitted electronically only if the initial ICSR for the SAE was submitted 
148  electronically. 
149   
150  E.  Product Names for Study Drugs 
151   
152  Submitters should use the drug substance name or nonproprietary name of the drug in the 
153  appropriate E2B data fields for study drugs (see section F).  The name should fit within the 
154  established E2B character lengths. 
155   
156  Submitters should report all drugs to which the subject was exposed using the appropriate E2B 
157  data fields referenced in FDAs technical specifications document FDA Regional Implementation 
158  Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and 
159  Biological Products.  Exposures to study drugs should be unblinded for the subject who 
160  experienced the SAE before submission.  Knowledge of the treatments and interventions 
161  received is necessary for interpreting the event, may be essential for the medical management of 
162  the subject, and may provide critical safety information about the study drug, which could have 
163  implications for the ongoing conduct of the study (e.g., monitoring, informed consent, other 
164  protocol modifications).29  FDA does not believe that unblinding single or small numbers of 
165  SAE cases will compromise the integrity of the study, in part because such unblinding should 
166  be infrequent.30 
167   
 
27 See the technical specifications document FDA Regional Implementation Guide for E2B(R3) Electronic 
Transmission of Individual Case Safety Reports for Drug and Biological Products. 
 
28 Safety Reporting Portal: Frequently Asked Questions What types of files may be attached to a report?, available 
at https://www.staging2.safetyreporting.hhs.gov/SRP2/en/FAQ.aspx. 
 
29 See the guidance for industry Safety Reporting Requirements for INDs and BA/BE Studies (December 2012), (see 
also the draft guidance for industry Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment 
for IND and Bioavailability/Bioequivalence Studies (June 2021)).  
 
30 Id. 
 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
168  F.  Description of Drug Exposure 
169   
170  Each of the subjects drug exposures should fit into one of the following classifications and E2B 
171  data fields: 
172   
173  (1) Past Drug Therapy  
174  Past drug therapy includes any drug the subject was taking before study enrollment that 
175  was discontinued before study initiation.  These drugs should be reported using section 
176  D.8.r titled Relevant Past Drug History.  The narrative should describe the indication, 
177  treatment regimen, duration of treatment, and the date of the last dose.  
178   
179  (2) Drug Exposure or Treatment During Study Enrollment and Follow-up Period 
180  Drug exposure or treatment during study enrollment may include test, reference, placebo, 
181  vehicle, and/or other drugs taken by or administered to the subject during the study or 
182  protocol-defined follow-up period.  These drugs should be reported using the 
183  recommendations below. 
184   
185  Table 1 displays the descriptions of the ICH E2B data elements (G.k.1, FDA.G.k.10a.r and 
186  G.k.2) used for reporting subjects drug exposures that occur after enrollment in the IND-exempt 
187  BA/BE study.  Submitters should use data element G.k.1 to characterize the drugs potential role 
188  in the SAE and data element FDA.G.k.10a.r to provide additional information on the drug 
189  exposure.  Submitters should use data elements G.k.2.2 and/or G.k.2.3.r.1 under G.k.2 to identify 
190  the drug by name.   
191   
192  Table 1. Descriptions of E2B Data Elements for Reporting Drug Exposure 
Data Element  Title  Element Values 
G.k.1  Characterization of Drug Role  1 = Suspect 
  2 = Concomitant 
3 = Interacting 
4 = Drug not administered 
FDA.G.k.10a.r  FDA Additional Information on  1 = Test  
Drug (coded)  2 = Reference  
nullFlavor=NA 
G.k.2  Drug identification  (Header  no element value) 
G.k.2.2  Medicinal Product Name as  Medicinal product name (free text) 
Reported by the Primary Source 
G.k.2.3.r.1  Substance/Specified Substance  Drug substance name (free text) 
Name 
193   
194  Submitters should provide the drug substance name using the data element G.k.2.3.r.1 and the 
195  medicinal product name (or proprietary name), if available, using the data element G.k.2.2.  If a 
196  drug has no proprietary name, submitters should only provide the drug substance name using the 
197  data element G.k.2.3.r.1 and leave the data element G.k.2.2 empty. The submitters should use 
198  one of the following element values for the data element FDA.G.k.10a.r: 1 for Test, 2 for 
199  Reference or 'NA' (nullFlavor) for all other drugs or if the information is not available. An ICSR 
200  should include completed data elements that describe the drug(s) to which the subject was 
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
201  exposed.   
202   
203  G.  Notification of Receipt of Electronic ICSR Submission by the FDA 
204   
205  See FDAs ESG website for further information about receipt of submissions through the ESG.31  
206  Acknowledgements and notifications indicating the status of each ICSR or ICSR attachment 
207  submission, successful acceptance or rejection with reason for rejection, are sent to the submitter.  
208  If the acknowledgements or notifications are not received, the submitter should contact the 
209  FAERS electronic submission coordinator at faersesub@fda.hhs.gov for assistance.   For 
210  information on the official FDA receipt date of the submission, refer to guidance for Industry 
211  Providing Regulatory Submissions in Electronic Format  Receipt Dates (February 2014). 
212   
213  For the SRP, upon completion and submission of the ICSR, the SRP will present a confirmation 
214  page that indicates the ICSR was successfully submitted.  This confirmation page is your official 
215  acknowledgement that FDA has received your completed report. 
216   
217  H.  Other Considerations 
218   
219  For submitting IND-exempt BA/BE safety reports as ICSRs, refer to the technical specifications 
220  document FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of 
221  Individual Case Safety Reports for Drug and Biological Products and the FAERS Electronic 
222  Submissions web page32 for the following information: 
223   
224    ICH E2B data elements  
225   
226    Regional specifications of the ICH E2B data elements 
227   
228    FDA ICSR XML instances with Read Me descriptions 
229   
230   
231  I.  Additional Supportive Resource 
232   
233    FDA E2B(R3) Core and Regional Data Elements and Business Rules, available at 
234  https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-
235  faers/fda-adverse-event-reporting-system-faers-electronic-submissions.  
 
31 See FDAs ESG Submission Process, available at https://www.fda.gov/industry/about-esg/esg-submission-
process. 
 
32 See FDA Adverse Event Reporting System (FAERS) Electronic Submissions available at 
https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-
reporting-system-faers-electronic-submissions. 
 
  8