Electronic Submission of IND Safety Reports Technical Conformance Guide : Guidance for Industry

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

ELECTRONIC SUBMISSION OF IND
SAFETY REPORTS
TECHNICAL CONFORMANCE GUIDE
This Document supplements the following Guidance Document:
Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND Safety
Reports (October 2019)
For questions regarding this technical specifications document, contact CDER or CBER at
faersesub@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)
Oncology Center of Excellence (OCE)
April 2022

ELECTRONIC SUBMISSION OF IND
SAFETY REPORTS
TECHNICAL CONFORMANCE GUIDE
April 2022

R EVISION H ISTORY
D ATE 	V ERSION 	S UMMARY OF MAJOR R EVISIONS
October 2019 	1.0 	Initial Version
April 2022 	1.1
• 	Added information regarding data elements needed for IND safety reports from
aggregate analysis
• 	Included provisions for submitting names of products without established
names to the IND prior to electronic submissions to FAERS
• 	Updated throughout to refer to IND safety reports submitted electronically to
FAERS as IND ICSRs
• 	Updated names of companion documents throughout

Contains Nonbinding Recommendations
Table of Contents
1. 	Introduction .......................................................................................................................... 1
1.1 	Background......................................................................................................................... 1
1.2 	Purpose ............................................................................................................................... 1
1.3 	Document Revision and Control ........................................................................................ 2
1.4 	Relationship to Other Documents....................................................................................... 2
2. 	General Considerations ........................................................................................................ 3
2.1 	IND Safety Report Submissions ......................................................................................... 3
2.1.1 	ICSR and ICH E2B Data Standards.......................................................................... 3
2.1.2 	IND Safety Reports ................................................................................................... 3
2.1.3 	IND Safety Reports That Should NOT Be Submitted to FAERS ............................ 3
2.1.4 	Transition to Submitting IND ICSRs to FAERS ...................................................... 5
2.1.5 	IND ICSR Attachments ............................................................................................ 5
2.1.6 	Follow-Up Reports.................................................................................................... 5
2.1.7 	Identification of the IND for Submissions of IND ICSRs ........................................ 5
2.1.7.1 	IND ICSRs From an Aggregate Analysis ............................................................ 6
2.1.8 	Product Names for Investigational Drugs ................................................................. 7
2.1.9 	Safety Reports for Marketed Drugs .......................................................................... 8
2.1.10 	Other Considerations ................................................................................................ 8
2.1.11 	Options For Electronic Submission of IND ICSRs: Electronic Submissions
Gateway or Safety Reporting Portal ......................................................................... 9
2.1.11.1 	Separate Submission Pathway for Submitting IND ICSRs to FAERS .............. 9
2.1.11.2 	Creating an Account Before the First Electronic Submission.......................... 10
2.1.11.3 	Unique Case Identification Numbers for IND Safety Reports ......................... 10
2.1.11.4 	Single Submission Versus Batched Submission of IND ICSRs ...................... 11
2.1.12 	Notification of Receipt of Submissions by the FDA .............................................. 11

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1
Electronic Submission of IND Safety Reports
Technical Conformance Guide1
This document represents the current thinking of the Food and Drug Administration (FDA or
Agency). It does not establish any rights for any person and is not binding on FDA or the public.
You can use an alternative approach if it satisfies the requirements of the applicable statutes and
regulations. To discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance or send an email to faersesub@fda.hhs.gov.
1. 	Introduction
1.1 Background
This Technical Conformance Guide (Guide) provides specifications, recommendations, and
general considerations on how to submit electronic investigational new drug application (IND)
safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for
Biologics Evaluation and Research (CBER). This Guide supplements the draft guidance for
industry Providing Regulatory Submissions in Electronic Format: IND Safety Reports (October
2019),2 which implements the electronic submission requirements of section 745A(a) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to electronic submissions for
certain IND safety reports submitted to CDER or CBER.
1.2 Purpose
This Guide discusses the format for the submission of IND safety reports required under 21 CFR
312.32(c)(1)(i) as individual case safety reports (ICSRs) to the FDA Adverse Event Reporting
System (FAERS) and provides recommendations to sponsors who elect to submit such ICSRs to
FAERS before the requirement for submission to FAERS is in effect for applicable INDs.3 This
Guide provides general information for sponsors of commercial and noncommercial INDs
pertaining to electronic submission of IND safety reports and attachments in electronic format to
1 This technical specifications document has been prepared by the Office of New Drugs in the Center for Drug
Evaluation and Research, in cooperation with the Center for Biologics Evaluation and Research and the Oncology
Center of Excellence, at the Food and Drug Administration. You may submit comments on this guidance at any
time. Submit comments to Docket No. FDA-2018-D-1216 (available at
https://www.regulations.gov/docket?D=FDA-2018-D-1216) (see the instructions for submitting comments in the
docket).
2 This guidance also provides information on the effective date of the requirement to provide certain regulatory
submissions in electronic format. When final, this guidance will represent the FDA’s current thinking on this topic.
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.
3 FDA intends to post information on the FAERS Electronic Submissions web page (available at
https://www.fda.gov/drugs/fda-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-
electronic-submissions) when the Agency will begin accepting electronic submission of IND ICSRs to FAERS.

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FAERS. It also provides information to sponsors on the format for submission of IND safety
reports required under section 312.32(c)(1) that should not be submitted to FAERS and should
continue to be submitted in electronic common technical document (eCTD) format.4
1.3 Document Revision and Control
Sponsors will be able to access future revisions of this Guide through the FAERS Electronic
Submissions web page,5 and the revision history page of this Guide will provide information on
the changes made to previous versions.
1.4 Relationship to Other Documents
Sponsors should consult the following guidances and web pages for other aspects of electronic
IND safety reporting:
• 	Draft guidance for industry Providing Regulatory Submissions in Electronic Format:
IND Safety Reports6
• 	Technical specifications document FDA Regional Implementation Guide for E2B(R3)
Electronic Transmission of Individual Case Safety Reports for Drug and Biological
Products (April 2022)7
• 	The FAERS Electronic Submissions web page for instructions on submission of ICSRs
• 	Guidance for industry Providing Submissions in Electronic Format — Postmarketing
Safety Reports (April 2022) for instructions on contingency plans for submission of
safety reports, for notification of receipt of submissions, and contingencies when the
submissions systems are temporarily unavailable
4 See also the draft guidance for industry Providing Regulatory Submissions in Electronic Format: IND Safety
Reports. When final, this guidance will represent the FDA’s current thinking on this topic.
5 Available on the FAERS Electronic Submissions web page at https://www.fda.gov/drugs/fda-adverse-event-
reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions.
6 When final, this guidance will represent the FDA’s current thinking on this topic.
7 Available on the FAERS Electronic Submissions web page at https://www.fda.gov/drugs/fda-adverse-event-
reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions.

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2. 	General Considerations
2.1 IND Safety Report Submissions
2.1.1 	ICSR and ICH E2B Data Standards
An ICSR is a description of an adverse drug event experienced by an individual subject. ICSRs
are used to communicate information on clinical trial and postmarketing adverse drug events or
adverse drug reactions between a variety of entities involved with the review and tracking of
safety information (e.g., investigators, regulators, pharmaceutical companies, institutional review
boards or ethics committees, reporters).
The International Council for Harmonisation (ICH) E2B data standards working group was
created to provide common data elements for the electronic transmission of ICSRs globally
between relevant stakeholders. FDA currently requires mandatory postmarketing safety reports
to be submitted to FAERS8 and Vaccine Adverse Event Reporting System (VAERS) and certain
IND safety reports will also be required to be submitted to FAERS when the requirement is in
effect.9
2.1.2 	IND Safety Reports
Certain IND safety report types required under 21 CFR 312.32(c)(1) contain individual data from
one or more subjects and should be submitted as ICSRs to FAERS (hereafter, for the purposes of
this document, these types of reports are referred to as IND ICSRs). Other types of required IND
safety reports are reports of overall findings or pooled analyses from published and unpublished
in vitro, animal, epidemiological, or clinical studies. The sponsor should submit these other
types of reports in a narrative format in eCTD format and should not submit the reports to
FAERS (see details in section 2.1.3 below).
2.1.3 	IND Safety Reports That Should NOT Be Submitted to FAERS
IND safety reports that are not submitted to FAERS (see Table 1) are reports of overall findings
or pooled analyses from published and unpublished in vitro, animal, epidemiological, or clinical
studies and increased rate of occurrences of serious suspected adverse reactions. Reports of
overall findings or pooled analyses as noted above are to be submitted in a narrative format (21
CFR 312.32(c)(1)(v)). These reports should be submitted in the following manner:
8 See the guidance for industry Providing Submissions in Electronic Format — Postmarketing Safety Reports.
9 For information on the effective date of the requirement, see the draft guidance for industry Providing Regulatory
Submissions in Electronic Format: IND Safety Reports. When final, this guidance will represent the FDA’s current
thinking on this topic.

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• 	For INDs10 in eCTD format11 using the following labels:
− 	For findings from animal or in vitro testing (21 CFR 312.32(c)(1)(iii)): to the
appropriate study using the “Safety Report” file-tag in eCTD section 4.2.3,
Toxicology
− 	For findings from other studies (21 CFR 312.32(c)(1)(ii)) and for an increased rate of
occurrence of serious suspected adverse reactions (21 CFR 312.32(c)(1)(iv)): using
the “Safety Report” file-tag in eCTD section 5.3.5.4, Other Safety Reports and
Related Information
These IND safety reports in narrative format should not be submitted on MedWatch Form FDA
3500A or Council for International Organizations of Medical Sciences forms.
Table 1: Types of IND Safety Reports and Location of Submission
Type of report Submit to
FAERS*
Submit to
eCTD*
A single occurrence of an adverse event that is uncommon and
known to be strongly associated with drug exposure (21 CFR
312.32(c)(1)(i)(A))
X
One or more occurrences of an adverse event that is not
commonly associated with drug exposure, but is otherwise
uncommon in the population exposed to the drug (21 CFR
312.32(c)(1)(i)(B))
X
An aggregate analysis of specific adverse events observed in a
clinical trial (e.g., known consequences of the underlying
disease or condition under investigation, other events that
commonly occur in the study population independent of drug
therapy) that indicates those events occur more frequently in
the drug treatment group than in a concurrent or historical
control group (21 CFR 312.32(c)(1)(i)(C))
X
Findings from other studies (21 CFR 312.32(c)(1)(ii)) 	X
Findings from animal or in vitro testing (21 CFR
312.32(c)(1)(iii)) X
Increased rate of occurrence of serious suspected adverse
events (21 CFR 312.32(c)(1)(iv)) X
10 For a safety report submitted to a noncommercial IND that is not in eCTD format, see the guidance for industry
Providing Regulatory Submissions in Alternate Electronic Format (July 2021).
11 See guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human
Pharmaceutical Product Applications and Related Submissions Using eCTD Specifications (February 2020).

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* FAERS = FDA Adverse Event Reporting System; eCTD = electronic common technical document.
2.1.4 	Transition to Submitting IND ICSRs to FAERS
FDA will accept IND ICSRs to FAERS as part of a voluntary submission program prior to the
time that the requirement is in effect for applicable INDs.12
If sponsors choose to participate in the voluntary submission program, they should submit all
IND ICSRs to FAERS and should not switch back to submission in eCTD format. This will
allow for initial and follow-up reports and reports for cross-reported INDs to reside in the same
system from a given timepoint forward.
2.1.5 	IND ICSR Attachments
Attachments to IND ICSRs include supporting information, such as autopsy reports, or published
articles for IND ICSRs based on scientific literature. Attachments can also be used for narrative
portions of the IND ICSR that exceed character limitation for that E2B data field; however, FDA
encourages sponsors to construct informative narratives that fit within the character limitations.
2.1.6 	Follow-Up Reports
A follow-up report includes new information about an adverse drug reaction that has been
previously reported in an initial IND ICSR, and all follow-up reports should use the same unique
case identification number as the initial IND ICSR. Follow-up IND ICSRs should include all
information in the structured fields of the IND ICSR that has been previously reported along
with any new information. However, to avoid duplication, IND ICSR attachments such as
scientific literature or autopsy reports submitted with an initial IND ICSR should not be
resubmitted with a follow-up IND ICSR.
2.1.7 	Identification of the IND for Submissions of IND ICSRs
As discussed in the guidance for industry and investigators Safety Reporting Requirements for
INDs and BA/BE Studies (December 2012), IND safety reports should be submitted to all of the
sponsor’s INDs under which the drug is being administered. To submit IND safety reports to all
relevant INDs electronically to FAERS, the sponsor should create one IND ICSR using the
appropriate E2B data elements as described below.
For an IND ICSR to be successfully processed in FAERS, it needs to have one valid IND
number in the appropriate E2B data field. Sponsors should use the IND number under which the
clinical trial where the event occurs is conducted as the primary IND number in the indicated
E2B data field. Sponsors should also use the indicated repeatable E2B data field to list
individually other relevant INDs for which notification is necessary (i.e., cross-reporting) as
described in the guidance for industry and investigators Safety Reporting Requirements for INDs
12 Additional information on the voluntary submission process is available on the FAERS Electronic Submissions
web page at https://www.fda.gov/drugs/fda-adverse-event-reporting-system-faers/fda-adverse-event-reporting-
system-faers-electronic-submissions.

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and BA/BE Studies and the draft guidance for industry Sponsor Responsibilities — Safety
Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence
Studies (June 2021).13 The relevant FDA review staff for each IND identified in the FAERS
report will be notified that an IND ICSR has been submitted for that drug.
Sponsors should see the technical specifications document referenced in this Guide, FDA
Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety
Reports for Drug and Biological Products, for information on E2B data elements to populate
with the appropriate IND numbers as discussed above.
2.1.7.1 	IND ICSRs From an Aggregate Analysis
IND ICSRs that are a result of an aggregate analysis (21 CFR 312.32(c)(1)(i)(C)) of clinical
trials that are conducted under multiple INDs should be submitted to the parent IND using
electronic reporting to FAERS. The parent IND is the IND under which clinical trials were first
initiated in the United States. If the drug is being evaluated in multiple INDs, the parent IND is
generally the IND with the lowest number.
As discussed in the guidance for industry and investigators Safety Reporting Requirements for
INDs and BA/BE Studies, IND safety reports that are a result of an aggregate analysis should
include a narrative report (hereafter referred to as a narrative summary report) that provides a
summary of the cases and the analysis the sponsor conducted and should identify the individual
cases that contributed to the analysis. The sponsor should submit one IND ICSR to FAERS that
includes the following minimum information listed by E2B data element name with additional
clarifying information in parentheses:
− 	Sender’s (case) Safety Report Unique Identifier
− 	Type of Report (should = “Report from study”)
− 	Date of Most Recent Information for This Report
− 	Information on Sender of Case Safety Report (type, name, address, etc.)
− 	Local Criteria Report Type (15- or 7-day report)
− 	MedDRA Version for Reaction/Event14
− 	Reaction/Event (MedDRA code)
− 	Seriousness Criteria at Event Level (list most common criteria among all of the
individual cases)
− 	Characterisation of Drug Role
− 	Substance/Specified Substance Name
− 	Source of Assessment
− 	Result of Assessment
• 	The term aggregate in the E2B field “Patient” to indicate that the report is a report from
an aggregate analysis
13 When final, this guidance will represent the FDA’s current thinking on this topic.
14 MedDRA is an acronym for Medical Dictionary for Regulatory Activities.

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• 	The unique case identification number of each IND ICSR that contributed to the analysis,
listed in the appropriate E2B field as a linked report. If individual cases that contributed
to the analysis were previously submitted as IND safety reports in eCTD format, the
sponsor should list the eCTD sequence number15 and date of submission along with the
unique case identification number/manufacturer control number in the narrative summary
report that is attached to the IND ICSR as a PDF.
• 	The narrative summary report attached to the IND ICSR as a PDF and clearly titled
“Narrative summary report for an IND safety report from an aggregate analysis_IND
number_product_date of report.”
Sponsors should reference the technical specifications document FDA Regional Implementation
Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and
Biological Products for instructions on the appropriate data elements to include in IND ICSRs
from aggregate analyses as per 21 CFR 312.32(c)(1)(i)(C), on how to link all supportive IND
ICSRs to the report, and on where to include the narrative summary report. This information
may also be applicable for IND ICSRs submitted as per 21 CFR 312.32(c)(1)(i)(B) that include
more than one case and where a narrative summary report is provided.
2.1.8 	Product Names for Investigational Drugs
Sponsors should use the established name (generally the United States Adopted Name or
international nonproprietary name), if applicable, in the appropriate E2B product field for
investigational drugs. For investigational drugs without an established name, or if the
established name or the name of the active ingredient(s) in the product exceeds established E2B
character lengths, before submission of IND ICSRs to FAERS, the sponsor should submit to the
IND a general correspondence in eCTD format containing the full name of the medicinal
product, product name to be used for E2B reporting (FDA recommends company code, if
available), full name of the active ingredient(s), and active ingredient(s) name to be used for E2B
reporting as in Table 2 below.
15 The eCTD sequence number is the unique four-digit number for each IND submission the sponsor submits in the
us-regional.xml file for the eCTD submission.

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Table 2: Information to Include in “General Correspondence – Product E2B File” *
IND number 	Full name of
medicinal
product
Product name
to be used for
E2B reporting
(FDA
recommends
company code,
if available)
Full name of
the active
ingredient(s).
Separate
multiple
ingredients
with a
backslash
character (\)
Active
ingredient(s)
name to be used
for E2B
reporting
* IND = investigational new drug application; E2B = International Council for Harmonisation E2B data standards.
The document should be placed in “1.2 Cover letters,” and sponsors should clearly identify the
submission as “General Correspondence – Product E2B File”.
2.1.9 	Safety Reports for Marketed Drugs
For an adverse event associated with a marketed drug evaluated under an IND that meets IND
and postmarketing safety reporting requirements (21 CFR 312.32(c)(1)(i) and 314.80, 600.80, or
310.305), the sponsor should submit two separate ICSRs to FAERS: one ICSR referencing the
new drug application (NDA) or biologics license application (BLA) in the
“Authorization/Application Number” field and one IND ICSR referencing the IND as described
under section 2.1.7., Identification of the IND for Submissions of IND ICSRs.
For adverse events that occur with a marketed vaccine evaluated under an IND that meet IND
and postmarketing safety reporting requirements (21 CFR 312.32(c)(1)(i) and 600.80), the
sponsor should submit two separate ICSRs: one to VAERS for the BLA and one IND ICSR to
FAERS for the IND.
2.1.10 Other Considerations
Sponsors should reference the technical specifications document FDA Regional Implementation
Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and
Biological Products and the FAERS Electronic Submissions web page for the following
information:
• 	Required E2B data elements for IND ICSRs
• 	Regional specifications of the E2B data elements
• 	Use of E2B data elements for a variety of reporting scenarios

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• 	Submission of a narrative summary report as per 21 CFR 312.32(c)(1)(i)(C) or for several
reports submitted as per 21 CFR 312.32(c)(1)(i)(B)) and linking the unique case
identification numbers of the IND ICSRs supporting the narrative summary report
2.1.11 Options For Electronic Submission of IND ICSRs: Electronic Submissions
Gateway or Safety Reporting Portal
IND ICSRs (initial and follow-up reports and all attachments) for drugs addressed by this Guide
are submitted as IND ICSRs to the FAERS database.16 FDA provides two options for electronic
submission of IND ICSRs and attachments to FAERS: (1) direct submission through the
Electronic Submissions Gateway (ESG) or (2) submission through the Safety Reporting Portal
(SRP), both of which are available 24 hours a day, 7 days a week.
Direct submission of IND ICSRs through the ESG is described on the FAERS Electronic
Submissions web page. This option involves direct transmission of IND ICSRs from a firm’s
database to FDA through the ESG. The ESG is a central transmission point for sending
information electronically to FDA. Once received through the ESG, the submitted reports are
processed into the FAERS database. For instructions on organizing, preparing, and submitting
IND ICSRs and attachments using the direct submission method through the ESG, see the
technical specifications document FDA Regional Implementation Guide for E2B(R3) Electronic
Transmission of Individual Case Safety Reports for Drug and Biological Products. The
technical specifications document addresses topics such as data elements, electronic transport
format, and types of IND ICSR attachments FDA currently accepts.
The submission of IND ICSRs and IND ICSR attachments through the SRP is described on the
FDA’s SRP web page.17 Users enter the IND ICSR information manually into a web-based
form, and this information is then submitted to FDA to be uploaded into the FAERS database.
2.1.11.1 	Separate Submission Pathway for Submitting IND ICSRs to FAERS
FDA established a separate submission pathway within the ESG and SRP for submitting IND
ICSRs to FAERS to keep premarket and postmarketing reports separate in the FAERS database.
In addition, FDA created a new FDA region-specific data element to distinguish premarket and
postmarketing safety reports. Certain postmarketing data are periodically posted on the public
FAERS dashboard, and reports submitted through the premarket pathway will not be posted to
the public dashboard. . If an adverse event met both IND and postmarketing safety reporting
requirements the ICSR submitted to the postmarketing pathway will be subject to posting on the
FAERS public dashboard.
FDA has implemented business rules to identify IND ICSRs that are incorrectly submitted to the
postmarketing pathway in FAERS. Files submitted to the postmarketing pathway in FAERS
16 See the Questions and Answers on FAERS web page at https://www.fda.gov/drugs/surveillance/fda-adverse-
event-reporting-system-faers.
17 Available at https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=0183c2c0-8952-49cb-81f1-
0c3d37baa819.

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with certain criteria will be rejected and sponsors will receive a negative acknowledgement with
the reason for the rejection.18
2.1.11.2 	Creating an Account Before the First Electronic Submission
To submit IND ICSRs electronically, either through the ESG or SRP, the sponsor needs to have
an account with FDA. To create an account, the sponsor should contact the FAERS electronic
submissions coordinator at faersesub@fda.hhs.gov. The FAERS electronic submissions
coordinator will assist sponsors to ensure that all steps have been completed for successful
submission of IND ICSRs and attachments.
2.1.11.3 	Unique Case Identification Numbers for IND Safety Reports
Each IND ICSR should have a unique case identification number. The sponsor should use the
same unique case identification number for an initial IND ICSR and any of its follow-up reports
so that the reports can be associated with an individual case. Case identification numbers are
assigned based on one of the three methods of submission described below:
a. 	Via the SRP: The unique case identification number for an initial report is automatically
generated by the SRP once the IND ICSR is submitted.
b. 	Via the ESG: The unique case identification number for an initial report is generated by
the sponsor before submitting the report.
c. 	On Paper (e.g., MedWatch Form FDA 3500A):19 The unique case identification number
is the manufacturer control number that the sponsor assigns for the initial report.
The sponsor should use the same unique case identification number for an initial IND ICSR and
its follow-up reports even if there is a transfer of ownership of an application. If the current
sponsor submits a follow-up IND ICSR to an initial report submitted by a previous sponsor, the
current sponsor should use the unique case identification number from the initial IND ICSR to
ensure that the follow-up report can be matched with the initial submission.
Similarly, if the sponsor submits an initial IND ICSR through the ESG, the sponsor cannot
submit the follow-up reports for this case through the SRP because the initial and follow-up
reports will have different unique case identification numbers.
18 For additional details on rejection criteria for IND safety reports, see the FDA E2B(R3) Core and Regional Data
Elements and Business Rules document available on the FAERS Electronic Submissions web page at
https://www.fda.gov/drugs/fda-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-
electronic-submissions.
19 Sponsors who submit a follow-up report to FAERS for an earlier report that was submitted on paper or in eCTD
format should use the same manufacturer control number for the initial and all follow-up reports.

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2.1.11.4 	Single Submission Versus Batched Submission of IND ICSRs
When submitting IND ICSRs through the ESG, the sponsor can submit the reports either as a
single report or as several reports in a batch. See the technical specifications document FDA
Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety
Reports for Drug and Biological Products for information on submitting a single IND ICSR
versus a batch of IND ICSRs through the ESG.
If the sponsor is submitting IND ICSRs through the SRP, the sponsor can only submit a single
IND ICSR at a time because the SRP is not able to process a batched submission.
2.1.12 Notification of Receipt of Submissions by the FDA
For information on the notification of FDA’s receipt of a submission, see the guidance for
industry Providing Submissions in Electronic Format — Postmarketing Safety Reports and the
FAERS Electronic Submissions web page.