FDA Drug Topics

Electronic Submission of Safety Reports:

Ready for Primetime

Suranjan De
Deputy Director
Regulatory Science Staff
Office of Surveillance and Epidemiology
Center for Drug Evaluation and Research
 Overview

 Recognize that FDA will require reporting of IND and postmarket

safety reports to be submitted in the ICH E2B(R3) format to FAERS via
the Electronic Submission Gateway or the Safety Reporting Portal.
 Identify the updated requirements since the last publication that are
key for postmarket, IND, and IND-exempt BA/BE safety reporting.
 Describe the implementation status and progress of premarket and
postmarket safety reports in E2B (R3) format.
 Explain how to prepare for the electronic exchange of safety reports

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 Reporting in E2B(R3) format
 Implement electronic submission for both premarket and postmarket safety
report using ICH E2B(R3) data standard

 Separate Submission Path and Business Rules for permarket and postmarket
safety reports

 All Technical Specification documents posted on FAERS Electronic

Submission* web page

 All communication via FAERS Electronic Submission* web page on FDA.gov

*https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-
system-faers-electronic-submissions
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Approach to Triage ICSRs via ESG

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 Separate Submission Path

• Section N.1: Transmission Identification

– Batch Receiver Identifier (N.1.4) and Message Receiver Identifier (N.2.r.3)
AS2 Header Routing ID N.1.4 Value N.2.r.3 Value
Premarket CDER IND ICSR Destination: “CDER” XML Files: ZZFDA_PREMKT CDER_IND
XML Files: AERS_PREMKT_CDER FDA_AERS_PREMKT_CDER
CBER IND ICSR Destination: “CBER” XML Files: ZZFDA_PREMKT CBER_IND
XML Files: AERS_PREMKT_CBER FDA_AERS_PREMKT_CBER
CDER IND- Destination: “CDER” XML Files: ZZFDA_PREMKT CDER_IND_EXEMPT_BA_BE
exempt BA/BE XML Files: AERS_PREMKT_CDER FDA_AERS_PREMKT_CDER
ICSR
Postmarket Postmarket Destination: “CDER” XML Files: FDA_AERS ZZFDA CDER
ICSR XML Files: AERS

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Submission Methods

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 Safety Reporting Portal (SRP)

 SRP Intended for

 Sponsors and CROs without infrastructure for direct ESG (gateway-to-gateway) submission
 Individual reports only; no batch reporting via SRP
 Can be used for both commercial and research INDs safety reporting
 Not available for vaccine reporting
 If CRO
 Separate account needed for each sponsor/license holder

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 Safety Reporting Portal (SRP)
 Post-market and premarket reporting
 Maintained separately—select up front, can navigate between them
 Complete an on-line form
 Do not upload E2B R3 XML via SRP
 Emails acknowledgement on submission – keep for records
 “Free” (no added cost to use)
 Availability
 Both SRP and E2B R3 for premarket submission available at the same time
 No additional action required by existing SRP users for postmarket
reporting
 Contact FAERSESUB@fda.hhs.gov to request an SRP account
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 E2B (R3) FDA Implementation
Package
Filename: FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual
Case Safety Reports for Drug and Biological Products.pdf (August 2022)
Content: • Purpose of this technical specifications document is to assist submitters transmitting
electronic ICSRs with attachments to the (FAERS) database
• Describes FDA’s technical approach for submitting ICSRs, for incorporating its regionally
controlled terminology, and for implementing regional extensions that are not in ICH ICSR
IG

Filename: FDA E2B(R3) Core and Regional Data Elements and Business Rules – Version 1.6.xlsx
(January 2024)
Content: • Provides a comprehensive list of core ICH and FDA regional data elements, data element
attributes, conformance, business rules, XPaths and acknowledgement attributes
• Some of the regional data elements in this document are detailed in the FDA Regional
Implementation Technical Specification for E2B(R3)
• Revision History describes all the updates
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 E2B (R3) FDA Implementation
Package

Filename: FDA E2B(R3) Forward Compatible Rules.xlsx (April 2022)

Content: • Assist reporters and recipients in implementing systems with special focus on the
recommended rules for conversion of data from regional E2B R2 and regional E2B R3
• Applicable to postmarket safety reporting

Filename: FDA ICSR XML Instances.zip (September 2023)

Content: • This document lists the scenarios provided as FDA ICSR XML Instance and
acknowledgement examples based on FDA ICH E2B(R3) Technical Specifications
Document
• The zip file has a Read Me.txt file describing the different scenarios

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Submission for Different Types of
IND Safety Reports
 Not all IND safety reports will go to FAERS

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Benefits of electronic submission of
IND Safety Reports
No need to submit 1571 or cover letter for IND safety reports

No separate submission for cross-reported IND

Immediate acknowledgement of your ICSR submission

Additional Benefits

• Submit ICSR directly from your safety database

• Eliminates need to send ICSRs to your Regulatory Affairs

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 Updated Requirements

 Corrected XPath for FDA.G.k.12.r.11.r

 Corrected Xpath for FDA.G.k.12.r.2.r
 Corrected Xpath for FDA.C.2.r.2.8
 Removed rule for rejection "R0102"
 Updated rejection "R0008" to include C.5.4 = (1, 2 or 3) in the rule
 Updated values allowed for FDA.G.k.12.r.6 to use FDA Device Component
Code

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 Implementation Plan and Progress

*FDA Adverse Event Reporting System (FAERS) Electronic Submissions | FDA

Sponsors can now submit premarket and postmarket ICSRs in electronic format using
E2B(R3) standard or use the Safety Reporting Portal (SRP).
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Mechanism to validate E2B(R3) XML
files
 FDA has provided the FDA
E2B(R3) Validator* tool to
facilitate validation of the
E2B(R3) XML files generated
from your safety database
 This validator has a web-
based interface that enables
submitter to select a
E2B(R3) XML file and
validate
 The validation status and
results are displayed to the
user
*https://faers2-validator.preprod.fda.gov/LSMV/Validator
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 E2B R3 Implementation Plan
 Data Submission Changes for IND safety reports
eCTD

X
MedWatch Send

X
MedWatch to
FAERS

Regulatory FAERS
Sponsor FDA ESG Gateway Submissions

XML
XML

E2B XML E2B XML

April 1, 2024 April 1, 2026

Voluntary period to submit ICSRs electronically Mandatory electronic ICSR submission

FDA go-live with Mandatory ICSR submission

E2B R3 and SRP via ESG or SRP

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Proposed Implementation Timelines
APRIL 2024 – MARCH 2026 4
• Voluntary period to submit premarket
JANUARY 2024 3
and postmarket safety reports using
E2B(R3) standard
• Jan 16, 2024: FAERS accepts • Once moved to E2B(R3) standard,
postmarket safety reports in cannot revert to legacy methods
E2B(R3) data standard
APRIL 2026
• Jan 29, 2024: FAERS accepts
cosmetic safety reports
2 • April 1, 2026: Companies
must submit premarketing
and postmarketing ICSRs
• Voluntary period starts electronically to FAERS in
E2B(R3) format or SRP

1 APRIL 2024
• Published the final guidance along with FR
Notice
• April 1, 2024: FAERS accepts premarket safety
reports in E2B(R3) data standard or SRP
• Refer to FAERS Electronic Submission web page
for updates and Tech Specs
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 Electronic Submission Methods
Methods Setup Benefits

Direct to FDA Electronic  WebTrader or AS2 (System-to-System)  No need to submit 1571 or cover
Submission Gateway (ESG) using https://www.fda.gov/industry/electronic- letter for IND safety reports
E2B(R3) standard submissions-gateway
 No separate submission for cross-
 Generate E2B (R3) XML using the ICH reported IND
Implementation Guide and FDA Regional
Requirements  Immediate acknowledgement of
your submission
Safety Reporting Portal (SRP)  Contact faersesub@fda.hhs.gov to request
for SRP account  Submit reports directly from your
safety database (ESG)
 SRP account activation
 Account activated in about 7 to 10 business  Eliminates need to send ICSRs to
days from the date of request. your Regulatory Affairs
 Notified via email the Web link and
account information to start reporting.

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 Electronic Submission Methods

 Encourage to use the Safety Reporting Portal during

the E2B (R3) implementation period
 Once ready with E2B (R3) switch over to ESG
submission
 Please contact faersesub@fda.hhs.gov for questions
on the specification to support your implementation

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 Submitter Preparedness

Download the Guidance and

Prepare your safety database
Technical specification documents Review the regional extensions
accounting for the regional
posted on FAERS Electronic carefully
extensions
Submission web page

Account for the regional forward Generate the XML files and test Correct any issues identified by
compatibility R2 -> R3 them using the FDA E2B Validator the validator

Perform Gateway setup for AS2 Perform Gateway setup for AS2
Test sample XML files that has
Header / Routing ID in pre- Header / Routing ID in production
cleared FDA E2B Validator via the
production as defined in the FDA as defined in the FDA technical
pre-production Gateway
technical specification specification

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Submitting Reports via SRP

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Submitting Reports via SRP

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Submitting Voluntary Safety Reports
Electronically
 MedWatch Online
 Health professionals can voluntarily report observed or suspected adverse events for
human medical products to FDA
 Individual reports only; no batch reporting
 Submit via mobile device or a computer
 MedWatch Online allows reporters to start a report and complete it within 3 days.
 Reporters can save an incomplete report and provide an email address to receive
instructions on how to complete & submit a report with Report ID and Report Date.
 After submitting, you cannot retrieve the report and edit it

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 Information You Should Report to
MedWatch
 Unexpected side effects or adverse events can include everything from skin rashes to more
serious complications.
 Product quality problems such as information if a product isn't working properly or if it has a
defect.
 Product Use/Medication Errors that can be prevented. These can be caused by various issues,
including choosing the wrong product because of labels or packaging that look alike or have
similar brand or generic names. Mistakes also can be caused by difficulty with a device due to
hard-to-read controls or displays, which may cause you to record a test result that is not correct.
 Therapeutic failures. These problems can include when a medical product does not seem to
work as well when you switch from one generic to another.

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 Voluntary Reporting
Recommendations
 Fill in all the information possible to support detailed
analysis
 Provide detailed narrative of the incident/event
 Complete the structured data fields as much as possible
 Encourage reporters to provide their contact information
in case FDA needs more information

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Submitting Voluntary Safety Reports
via MedWatch Online

https://www.fda.gov/safety/medwatch-fda-safety-information-and-
adverse-event-reporting-program
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Submitting Voluntary Safety Reports
via MedWatch Online

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 Closing Thought

Use Safety Reporting Portal for mandatory

submission of IND safety report by
Investigators

Use MedWatch Online for submitting

voluntary safety reports by HCPs
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BA/BE Study Safety Reporting for Generic Drugs

Jung Lee, RPh, MPH

Division of Clinical Safety and Surveillance
Office of Safety and Clinical Evaluation
Office of Generic Drugs
Center for Drug Evaluation and Research
 Generic Drug Pharmacovigilance:
a Collaborative Process
Across FDA Centers:
• Center for Drug Evaluation and Research (CDER)
• Center for Devices and Radiological Health (CDRH)

Across CDER Offices:

• Office of Generic Drugs (OGD)
• Office of Surveillance and Epidemiology (OSE)
• Office of New Drugs (OND)
• Office of Pharmaceutical Quality (OPQ)
• Office of Compliance (OC)

Across OGD Offices:

• Office of Safety and Clinical Evaluation (OSCE)
• Office of Bioequivalence (OB)
• Office of Research and Standards (ORS)
• Office of Generic Drug Policy (OGDP)
• Office of Regulatory Operations (ORO)

www.fda.gov 30
 Generic Drug Pharmacovigilance

Phase Premarket Application Postmarket

Bio-IND
Safety Report1
Review
Flow of ANDA3
information Post-Approval
Adverse Event
Safety Report
Review
IND-exempt Review
BA/BE Safety Report2
Review

1Bio-IND Safety Report = A safety report submitted from a BA/BE study conducted under an Investigational New Drug application (IND).
Refer to MAPP 5210.5 rev. 3. (https://www.fda.gov/media/72562/download).
2IND-exempt BA/BE Safety Report = A safety report submitted from a BA/BE study NOT conducted under an IND.

3ANDA=Abbreviated New Drug Application

www.fda.gov 31
 BA/BE Study Safety Reporting Requirements
BA/BE studies conducted under an IND
• Must meet safety reporting requirements under 21 CFR 320.31 and 312.32
• Must submit an IND safety report(s) for an event(s) that meet(s) the following conditions:
1) serious, 2) unexpected and 3) suspected adverse reaction(s) => SUSARs
• Include individual case safety reports and aggregate reports

BA/BE studies NOT conducted under an IND

• Must meet IND exemption under 21 CFR 320.31
• Must meet expedited safety reporting requirements under 21 CFR 320.31(d)(3)-
The person conducting a BA or BE study, including any contract research organization, must notify
FDA and all participating investigators of any serious adverse event [SAE] observed during conduct
of the study, regardless of whether the event is considered drug related, as soon as possible but no
later than 15 calendar days after becoming aware of its occurrence.

www.fda.gov 32
 Generic Drug Premarket vs. Postmarket Safety Report
Submission & Review Prior to 4/1/24
Premarket
Report Type IND-exempt BA/BE Safety Postmarket Safety Reports
Bio-IND Safety Reports
Reports
Sponsors conducting Drug companies or CROs
Drug companies, healthcare
Source BA/BE studies conducted conducting BA/BE studies NOT
professionals, consumers, etc.
under an IND conducted under an IND
Format Form FDA 3500A Form FDA 3500A E2B
Submission
via database-to-database
via OGD Premarket email inbox,
(E2B) transmission
which is manually entered into
electronically or Safety
Route via eCTD the Panorama project tracking
Reporting Portal to the FDA
system. Initial and Follow-up also
Adverse Event Reporting
linked manually.
System (FAERS)

OGD/OSCE/DCSS reviews SAEs. OGD/OSCE/DCSS analyzes

OGD/OSCE/DCSS reviews
Review When ANDA is submitted, SAE and reviews safety reports in
SUSARs.
reviews are linked to ANDA. FAERS
33
www.fda.gov
 FAERS enhancements enabled electronic
submission of adverse events from premarket
BA/BE studies for generic drugs!

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 Electronic IND Safety Reporting Requirement
 IND safety reports as Individual Case Safety Reports (ICSRs) under 745A(a) of the
Federal Food Drug and Cosmetic (FD&C) Act
• April 1, 2024: Final Guidance for Industry- Providing Regulatory Submissions in
Electronic Format: IND Safety Reports
• Sponsors of commercial INDs required to submit specified IND safety reports to FAERS
have two options:
o Electronic Submissions Gateway (E2B Transmission)
o Safety Reporting Portal
• Begin voluntary submissions in E2B(R3) format (April 1, 2024)
• Requirement 24 months after Final Guidance publication (April 1, 2026)

 Bio-IND Safety Reports (from BA/BE studies conducted under an IND) must meet
the electronic ICSR reporting requirement under 745A(a) of the FD&C Act.

www.fda.gov 35
 IND-exempt BA/BE Safety Reporting
A. Options for submission:
1. May continue to email Form FDA 3500A to OGD-PremarketSafetyReports@fda.hhs.gov.

2. FAERS enhancements for premarket safety reports are available:

 E2B format is a new option available to notify the FDA of an SAE(s) from
BA/BE studies NOT conducted under an IND required under 21 CFR 320.31(d)(3).

 Options for submitting IND-exempt BA/BE Safety Reports as ICSRs in E2B(R3) format
• Electronic Submission Gateway (E2B Transmission) <- Today’s Focus
• Safety Reporting Portal

www.fda.gov 36
 Voluntary Electronic Submission of
IND-exempt BA/BE Safety Reports
B. Electronic Submission Gateway (E2B Transmission) Option:
1. Understand requirements4,5
• FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual
Case Safety Reports for Drug and Biological Products Guidance for Industry Technical
Specifications Document (hereafter referred as Technical Specifications Document)
• Final Guidance for Industry: Electronic Submission of Expedited Safety Reports from
IND-exempt BA/BE studies (April 2024)

Additional resources:
• Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments
• E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs)
Implementation Guide –Data Elements and Message Specification
• FDA E2B(R3) Core and Regional Data Elements and Business Rules

4 Search for FDA Guidance Documents (https://www.fda.gov/regulatory-information/search-fda-guidance-documents).

5 FAERS Electronic Submissions-standards (https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-
system-faers-electronic-submissions-e2br3-standards).
www.fda.gov 37
 Voluntary Electronic Submission of
IND-exempt BA/BE Safety Reports

2. Prepare IT system
• FAERS started accepting premarket ICSRs in E2B (R3) format on April 1, 2024.
• Learn the specifications for preparing and submitting electronic submission of ICSRs.
• Need an account with FDA to submit ICSRs electronically.
• Notify the FAERS electronic submission coordinator at faersesub@fda.hhs.gov to create an
account.

3. Obtain pre-assigned ANDA number (‘Pre-ANDA’)6,7

• Request using CDER NextGen Portal prior to:
-> Submitting an SAE(s) from the BA/BE study or
-> Starting subject recruitment for the BA/BE study

6 Requesting a Pre-Assigned Application number (https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/requesting-pre-assigned-application-number).

7 CDER NextGen Portal (https://cdernextgenportal.fda.gov/Login_CDER?ec=302&startURL=%2Fs%2F).
www.fda.gov 38
 Voluntary Electronic Submission of
IND-exempt BA/BE Safety Reports
4. Identify ICSRs from IND-exempt BA/BE studies
a. Include submission path business rules
AS2 Header Routing ID N.1.4 Value N.2.r.3 Value
Premarket CDER IND ICSR Destination: “CDER” XML Files: ZZFDA_PREMKT CDER_IND
XML Files: AERS_PREMKT_CDER FDA_AERS_PREMKT_CDER
CBER IND ICSR Destination: “CBER” XML Files: ZZFDA_PREMKT CBER_IND
XML Files: AERS_PREMKT_CBER FDA_AERS_PREMKT_CBER
CDER IND-exempt Destination: “CDER” XML Files: ZZFDA_PREMKT CDER_IND_EXEMPT_BA_BE
BA/BE ICSR XML Files: AERS_PREMKT_CDER FDA_AERS_PREMKT_CDER
Postmarket Postmarket ICSR Destination: “CDER” XML Files: FDA_AERS ZZFDA CDER
XML Files: AERS

Message receiver identifier: N.2.r.3 & Batch receiver Identifier: N.1.4

b. Choose element value=2 for ‘Report from study’ as the ‘Type of Report’ in Data Element C.1.3
Data element Title Element value

C.1.3 Type of Report 2=Report from study

www.fda.gov 39
 Voluntary Electronic Submission of
IND-exempt BA/BE Safety Reports
4. Identify ICSRs from IND-exempt BA/BE studies
c. Submit Pre-assigned ANDA (‘Pre-ANDA’)8 number
Data element Title Element values
FDA.C.5.5b Pre-ANDA Number where AE Numeric
Occurred
 Max Length: 10
 Data Type: Numeric (N) (For example, “234567“)
 Conformance: Conditional-Required
 Business Rule:
• If Type of Report (C.1.3) is 2=Report from study and
Message Receiver Identifier (N.2.r.3) = “CDER_IND_EXEMPT_BA_BE”
then Pre-ANDA Number where AE Occurred (FDA.C.5.5b) is required.
• Required to be a valid Pre-ANDA number for processing and routing

8Although these are pre-assigned ANDA numbers and the term ‘Pre-ANDA’ is being used with these numbers, each submission may or may not be associated
with the Office of Generic Drug’s Pre-ANDA Program (https://www.fda.gov/drugs/generic-drugs/pre-anda-program) for complex drug products .
www.fda.gov 40
 Voluntary Electronic Submission of
IND-exempt BA/BE Safety Reports
5. Identify drug substance
Data element Title Element values
G.k.2.2 Medicinal Product Name as Reported by Medicinal product name (free text)
the Primary Source
G.k.2.3.r.1 Substance/Specified Substance Name Drug substance name (free text)

• Report medicinal product name (proprietary name) using data element G.k.2.2 if available.
• Report drug substance name in data element G.k.2.3.r.1
• Report only drug substance name if medicinal product name (proprietary name) is not available.

6. Characterize drug’s role

Data element Title Element values

G.k.1 Characterization of Drug Role 1 = Suspect

2 = Concomitant
3 = Interacting
4 = Drug not administered
www.fda.gov 41
 Voluntary Electronic Submission of
IND-exempt BA/BE Safety Reports
7. Inform Test vs. Reference* Unique to generic drugs
Data element Title Element values
FDA.G.k.10.a.r FDA Additional Information on 1 = Test
Drug 2 = Reference
nullFlavor=NA
 Max Length: 2​
 Data Type: Numeric (N)​
 Conformance: Conditional-Required
 Business Rule​:
• If Pre-ANDA Number where AE Occurred (FDA.C.5.5b) is present, then the Observation Code: (Value allowed: 1, 2)
must be used to describe the drug’s role in the IND-Exempt BA/BE study.
• Use nullFlavor: NA for all other drugs or if information is not available.

www.fda.gov 42
 Voluntary Electronic Submission of
IND-exempt BA/BE Safety Reports
8. Other considerations
• Refer to the Technical Specifications Document for information on:
 ICH E2B data elements

 Regional specifications

9. Check examples if needed

• FDA ICSR XML instances with Read Me descriptions are available at the FAERS
electronic submission web page9

10. Look for FDA Notification of Receipt

• Review Acknowledgements & Notifications indicating the status of submission,
successful acceptance or rejection with reason for rejection after submission.
• Contact the FAERS electronic submission coordinator at faersesub@fda.hhs.gov if the
acknowledgements or notifications are not received.

9FAERS Electronic Submissions-standards (https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-

reporting-system-faers-electronic-submissions-e2br3-standards).
www.fda.gov 43
 Voluntary Electronic Submission of
IND-exempt BA/BE Safety Reports
C. Advantages:
1. Non-public space
• FAERS uses specific data fields (such as E2B data element FDA.C.5.5b for IND-
exempt BA/BE Safety Reports) to identify pre-market reports and sequester them
from postmarket reports that are available in the public portal.
2. Increased efficiencies
• One submission method
1) IND-exempt BA/BE safety reports
2) Bio-IND safety reports
3) Postmarket safety reports
• Automated confirmation of receipt
3. Support generic drug pharmacovigilance
• Improved generic drug signal detection
• Enhanced data management & analytics

www.fda.gov 44
 Acknowledgements
• Howard Chazin, OGD/OSCE/DCSS Director
• Debra Catterson, OGD/OSCE/DCSS Deputy Director
• James Osterhout, OGD/OSCE/DCSS Senior Data Scientist
• Suranjan De, Office of Surveillance and Epidemiology/
Regulatory Science Staff​/Deputy Director

www.fda.gov 45
 References
Document / Web Page Accessible At
FDA Adverse Event Reporting System (FAERS) https://www.fda.gov/drugs/questions-and-answers-fdas-
Electronic Submissions –Web page adverse-event-reporting-system-faers/fda-adverse-event-
reporting-system-faers-electronic-submissions
FDA Regional Implementation Guide for E2B(R3) https://www.fda.gov/regulatory-information/search-fda-
Electronic Transmission of Individual Case Safety guidance-documents/fda-regional-implementation-guide-e2br3-
Reports for Drug and Biological Products (Apr 2024) electronic-transmission-individual-case-safety-reports-drug
FDA E2B(R3) Core and Regional Data Elements and https://www.fda.gov/media/157982/download
Business Rules v1.6 (Apr 2024)
FDA E2B(R3) Forward Compatible Rules (Apr 2022) https://www.fda.gov/media/157993/download
FDA ICSR XML Instances (Feb 2024) https://www.fda.gov/media/157983/download
Electronic Submission of IND Safety Reports - https://www.fda.gov/regulatory-information/search-fda-
Technical Conformance Guide (Apr 2022) guidance-documents/electronic-submission-ind-safety-reports-
technical-conformance-guide
Electronic Submission of Expedited Safety Reports https://www.fda.gov/regulatory-information/search-fda-
From IND-Exempt BA/BE Studies - Draft Guidance guidance-documents/electronic-submission-expedited-safety-
for Industry (Apr 2024) reports-ind-exempt-babe-studies-guidance-industry
Preparing for the electronic exchange of safety https://www.fda.gov/media/177186/download?attachment
reports
46