Version 2.3.3
The Comprehensive Table of Contents Headings and Hierarchy
Revision History
Date
Version
Summary of Changes
2004-07
1.0
Original version
2005-06-16
1.1
Corrections and additions to the mapping tables
2005-07-06
1.2
Corrections to the headings
2012-06-01
2.0
Corrections and additions to the mapping tables based on major
update to Module 1 specifications (Summary of Changes in Section
C of Appendix 2)
2012-11-01
2.1
Modified the heading for 1.16 and added REMS and non-REMS
sub-headings (Summary of Changes in Section B of Appendix 2)
2013-08-23
2.2
Added two new attributes for 1.15.2.1 (Summary of Changes in
Section A of Appendix 2)
2014-02-07
2.3
Modified the heading for 1.15.1.5 (Summary of Changes in Section
A of Appendix 2)
2017-04-17
2.3.1
Updated heading names under sections 4.2.1.1, 5.3.1.1, 5.3.5.3 to
align with file tags in ICH valid values version 3.0.
2018-11-01
2.3.2
Fixed page numbering and updated content under sections 5.3.5.3
and 5.3.5.4
2020-11-09
2.3.3
Added file tags under sections 4.2.1.1, 5.3.1.1, and 5.3.5.4 to align
with file tags in ICH valid values version 5.0.
Version 2.3.3
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Table of Contents
The Comprehensive Table of Contents Headings and Hierarchy .............................................................. 1
Module 1 Administrative information .......................................................................................... 1
Module 2 Summaries .................................................................................................................. 4
Module 3 Quality ....................................................................................................................... 5
Module 4 Nonclinical Study Reports ............................................................................................ 6
Module 5 Clinical Study Reports ................................................................................................. 9
Appendix 1 – Mapping Section...................................................................................................13
Appendix 2 – Module 1 Summary of Changes .............................................................................39
A. Module 1 Summary of Changes (02/07/2014, version 2.3)
.........................................................39
B. Module 1 Summary of Changes (08/23/2013, version 2.2)
.........................................................39
C. Module 1 Summary of Changes (11/1/2012, version 2.1)
...........................................................39
D. Module 1 Summary of Changes (6/1/2012, version 2.0) ............................................................40
Version 2.3.3
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The Comprehensive Table of Contents Headings and Hierarchy
Module 1 Administrative information
1.1 Forms
Form [form-type]
1.2 Cover letters
1.3 Administrative information
1.3.1 Contact/sponsor/applicant information
1.3.1.1 Change of address or corporate name
1.3.1.2 Change in contact/agent
1.3.1.3 Change in sponsor
1.3.1.4 Transfer of obligation
1.3.1.5 Change in ownership of an application or reissuance of license
1.3.2 Field copy certification
1.3.3 Debarment certification
1.3.4 Financial certification and disclosure
1.3.5 Patent and exclusivity
1.3.5.1 Patent information
1.3.5.2 Patent certification
1.3.5.3 Exclusivity claim
1.3.6 Tropical disease priority review voucher
1.4 References
1.4.1 Letter of authorization
1.4.2 Statement of right of reference
1.4.3 List of authorized persons to incorporate by reference
1.4.4 Cross-reference to previously submitted information
1.5 Application status
1.5.1 Withdrawal of an IND
1.5.2 Inactivation request
1.5.3 Reactivation request
1.5.4 Reinstatement request
1.5.5 Withdrawal of an unapproved BLA, NDA, ANDA, or Supplement
1.5 6 Withdrawal of listed drug
1.5.7 Withdrawal of approval of an application or revocation of license
1.6 Meetings
1.6.1 Meeting request
1.6.2 Meeting background materials
1.6.3 Correspondence regarding meetings
1.7 Fast track
1.7.1 Fast track designation request
1.7.2 Fast track designation withdrawal request
1.7.3 Rolling review request
1.7.4 Correspondence regarding fast track/rolling review
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1.8 Special protocol assessment request
1.8.1 Clinical study
1.8.2 Carcinogenicity study
1.8.3 Stability study
1.8.4 Animal efficacy study for approval under the animal rule
1.9 Pediatric administrative information
1.9.1 Request for waiver of pediatric studies
1.9.2 Request for deferral of pediatric studies
1.9.3 Request for pediatric exclusivity determination
1.9.4 Proposed pediatric study request and amendments
1.9.5 Proposal for written agreement (no longer applicable)
1.9.6 Other correspondence regarding pediatric exclusivity or study plans
1.10 Dispute resolution
1.10.1 Request for dispute resolution
1.10.2 Correspondence related to dispute resolution
1.11 Information amendment: Information not covered under modules 2 to 5
1.11.1 Quality information amendment
1.11.2 Nonclinical information amendment
1.11.3 Clinical information amendment
1.11.4 Multiple module information amendment
1.12 Other correspondence
1.12.1 Pre IND correspondence
1.12.2 Request to charge for clinical trial
1.12.3 Request to charge for expanded access
1.12.4 Request for comments and advice
1.12.5 Request for a waiver
1.12.6 Exception from informed consent for emergency research
1.12.7 Public disclosure statement for exception from informed
consent for emergency research
1.12.8 Correspondence regarding exception from informed
consent for emergency research
1.12.9 Notification of discontinuation of clinical trial
1.12.10 Generic drug enforcement act statement
1.12.11 ANDA basis for submission statement
1.12.12 Comparison of generic drug and reference listed drug
1.12.13 Request for waiver for in vivo studies
1.12.14 Environmental analysis
1.12.15 Request for waiver of in vivo bioavailability studies
1.12.16 Field alert reports
1.12.17 Orphan drug designation
1.13 Annual report
1.13.1 Summary for nonclinical studies
1.13.2 Summary of clinical pharmacology information
1.13.3 Summary of safety information
1.13.4 Summary of labeling changes
1.13.5 Summary of manufacturing changes
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1.13.6 Summary of microbiological changes
1.13.7 Summary of other significant new information
1.13.8 Individual study information
1.13.9 General investigational plan
1.13.10 Foreign marketing
1.13.11 Distribution data
1.13.12 Status of postmarketing study commitments and requirements
1.13.13 Status of other postmarketing studies and requirements
1.13.14 Log of outstanding regulatory business
1.13.15 Development safety update report (DSUR)
1.14 Labeling
1.14.1 Draft labeling
1.14.1.1 Draft carton and container labels
1.14.1.2 Annotated draft labeling text
1.14.1.3 Draft labeling text
1.14.1.4 Label comprehension studies
1.14.1.5 Labeling history
1.14.2 Final labeling
1.14.2.1 Final carton or container labels
1.14.2.2 Final package insert (package inserts,
patient information, medication guides)
1.14.2.3 Final labeling text
1.14.3 Listed drug labeling
1.14.3.1 Annotated comparison with listed drug
1.14.3.2 Approved labeling text for listed drug
1.14.3.3 Labeling text for reference listed drug
1.14.4 Investigational drug labeling
1.14.4.1 Investigational brochure
1.14.4.2 Investigational drug labeling
1.14.5 Foreign labeling
1.14.6 Product labeling for 2253 submissions
1.15 Promotional material [promotional-material-audience-type]
1.15.1 Correspondence relating to promotional materials
1.15.1.1 Request for advisory comments on launch materials
1.15.1.2 Request for advisory comments on non-launch
materials
1.15.1.3 Presubmission of launch promotional materials for
accelerated approval products
1.15.1.4 Presubmission of non-launch promotional materials for
accelerated approval products
1.15.1.5 Pre-dissemination review of television ads
1.15.1.6 Response to untitled letter or warning letter
1.15.1.7 Response to information request
1.15.1.8 Correspondence accompanying materials previously
missing or rejected
1.15.1.9 Withdrawal request
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1.15.1.10 Submission of annotated references
1.15.1.11 General correspondence
1.15.2 Materials attribute = [promotional-material-doc-type]
1.15.2.1 Material [promotional-material-type, material-id, issue- date]
1.15.2.1.1 Clean version
1.15.2.1.2 Annotated version
1.15.2.1.3 Annotated labeling version
1.15.2.1.4 Annotated references
1.16 Risk management plan
1.16.1 Risk Management (Non-REMS)
1.16.2 Risk Evaluation and Mitigation Strategy (REMS)
1.16.2.1 Final REMS
1.16.2.2 Draft REMS
1.16.2.3 REMS Assessment
1.16.2.4 REMS Assessment Methodology
1.16.2.5 REMS Correspondence
1.16.2.6 REMS Modification History
1.17 Postmarketing studies
1.17.1 Correspondence regarding postmarketing commitments
1.17.2 Correspondence regarding postmarketing requirements
1.18 Proprietary names
1.19 Pre-EUA and EUA
1.20 General investigational plan for initial IND
Module 2 Summaries
2.2 Introduction to summary
2.3 Quality overall summary
2.4 Nonclinical overview
2.5 Clinical overview
2.6 Nonclinical written and tabulated summaries
2.6.1 Introduction
2.6.2 Pharmacology written summary
2.6.3 Pharmacology tabulated summary
2.6.4 Pharmacokinetic written summary
2.6.5 Pharmacokinetic tabulated summary
2.6.6 Toxicology written summary
2.6.7 Toxicology tabulated summary
2.7 Clinical summary
2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical
Methods
2.7.2 Summary of Clinical Pharmacology studies
2.7.3 Summary of Clinical Efficacy [indication]
2.7.4 Summary of Clinical Safety
2.7.5 References
2.7.6 Synopses of individual studies
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Module 3 Quality
3.2 Body of data
3.2.S Drug substance [name, manufacturer]
3.2.S.1 General information
3.2.S.1.1 Nomenclature
3.2.S.1.2 Structure
3.2.S.1.3 General properties
3.2.S.2 Manufacture
3.2.S.2.1 Manufacturer(s)
3.2.S.2.2 Description of Manufacturing Process and Process Controls
3.2.S.2.3 Control of Materials
3.2.S.2.4 Controls of Critical Steps and Intermediates
3.2.S.2.5 Process Validation and/or Evaluation
3.2.S.2.6 Manufacturing Process Development
3.2.S.3 Characterization
3.2.S.3.1 Elucidation of Structure and other Characteristics
3.2.S.3.2 Impurities
3.2.S.4 Control of drug substance
3.2.S.4.1 Specification
3.2.S.4.2 Analytical Procedures
3.2.S.4.3 Validation of Analytical Procedures
3.2.S.4.4 Batch Analyses
3.2.S.4.5 Justification of Specification
3.2.S.5 Reference standards or materials
3.2.S.6 Container closure systems
3.2.S.7 Stability
3.2.S.7.1 Stability Summary and Conclusions
3.2.S.7.2 Post Approval Stability Protocol and Stability Commitment
3.2.S.7.3 Stability Data
3.2.P Drug product [name, dosage form, manufacturer]
3.2.P.1 Description and composition of the drug product
3.2.P.2 Pharmaceutical development
3.2.P.3 Manufacture
3.2.P.3.1 Manufacturer(s)
3.2.P.3.2 Batch Formula
3.2.P.3.3 Description of Manufacturing Process and Process Controls
3.2.P.3.4 Controls of Critical Steps and Intermediates
3.2.P.3.5 Process Validation and/or Evaluation
3.2.P.4 Control of excipients [name]
3.2.P.4.1 Specification(s)
3.2.P.4.2 Analytical Procedures
3.2.P.4.3 Validation of Analytical Procedures
3.2.P.4.4 Justification of Specifications
3.2.P.4.5 Excipients of Human or Animal Origin
3.2.P.4.6 Novel Excipients
3.2.P.5 Control of drug product
3.2.P.5.1 Specification(s)
3.2.P.5.2 Analytical Procedures
3.2.P.5.3 Validation of Analytical Procedures
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3.2.P.5.4 Batch Analyses
3.2.P.5.5 Characterization of Impurities
3.2.P.5.6 Justification of Specification(s)
3.2.P.6 Reference standards or materials
3.2.P.7 Container closure system
3.2.P.8 Stability
3.2.P.8.1 Stability Summary and Conclusion
3.2.P.8.2 Postapproval Stability Protocol and Stability Commitment
3.2.P.8.3 Stability Data
3.2.A Appendices
3.2.A.1 Facilities and Equipment [name, manufacturer]
3.2.A.2 Adventitious agents safety evaluation [name, dosage form,
manufacturer]
3.2.A.3 Novel excipients
3.2.R Regional information
3.3 Literature references
Module 4 Nonclinical Study Reports
4.2 Study reports
4.2.1 Pharmacology
4.2.1.1 Primary pharmacodynamics
Study report [identification number] and related information
Legacy clinical study report
Pre clinical study report
Synopsis
Study report body
Protocol or amendment
Signatures investigators
Audit certificates report
Statistical methods interim analysis plan
Inter-laboratory standardisation methods quality assurance
Publications based on study
Publications referenced in report
Compliance and drug concentration data
Data
tabulation
Data tabulation
dataset legacy
Data tabulation dataset send
Data tabulation data definition
Data listing dataset
Data listing dataset
Data listing data definition
Ana lysis datasets
Analysis dataset adam
Analysis dataset legacy
Analysis program
Analysis data definition
Safety report
Assay validation
Biomarkers
Data monitoring review committees
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Device information
Diagnostic tests
Gene therapy
Pharmacodynamics
Pharmacogenomics
Pharmacokinetics
Stem cells
Antibody
Other data not specified
PK PD relationship
Specialty report
Foreign clinical studies not under ind
4.2.1.2 Secondary pharmacodynamics
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.1.3 Safety pharmacology
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.1.4 Pharmacodynamic drug interactions
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.2 Pharmacokinetics
4.2.2.1 Analytical methods and validation reports
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.2.2 Absorption
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.2.3 Distribution
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.2.4 Metabolism
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.2.5 Excretion
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.2.6 Pharmacokinetic drug interactions
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for heading
4.2.2.7 Other pharmacokinetic studies
Study report [identification number] and related information
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See Primary pharmacodynamics Study report and related
information for headings
4.2.3 Toxicology
4.2.3.1 Single dose toxicity [Species and route]
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.2 Repeat dose toxicity [Species, route, duration]
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.3 Genotoxicity
4.2.3.3.1 In vitro
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.3.2 In vivo
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.4 Carcinogenicity
4.2.3.4.1 Long term studies [Species]
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.4.2 Short or medium term studies
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.4.3 Other studies
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.5 Reproductive and developmental toxicity
4.2.3.5.1 Fertility and early embryonic development
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.5.2 Embryofetal development
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.5.3 Prenatal and postnatal development, including maternal function
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.5.4 Studies in which the offspring (juvenile animals) are dosed
and/or further evaluated
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
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4.2.3.6 Local tolerance
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.7 Other toxicity studies
4.2.3.7.1 Antigenicity
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.7.2 Immunotoxicity
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.7.3 Mechanistic studies
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.7.4 Dependence
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.7.5 Metabolites
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.7.6 Impurities
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.2.3.7.7 Other
Study report [identification number] and related information
See Primary pharmacodynamics Study report and related
information for headings
4.3 Literature references
Module 5 Clinical Study Reports
5.2 Tabular listing of all clinical studies
5.3 Clinical study reports and related information
5.3.1 Reports of biopharmaceutic studies
5.3.1.1 Bioavailability (BA) Study reports and related
information
Study report [identification] and related information
Legacy clinical study report
Synopsis (ICH E3, section 2)
Study report body (E3 1, 3 to 15)
Protocol or amendment (E3 16.1.1)
Sample case report form (E3 16.1.2)
IEC-IRB consent form list (E3 16.1.3)
List description investigator site (E3 16.1.4)
Signatures investigators (E3 16.1.5)
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List patients with batches (E316.1.6)
Randomisation scheme (E3 16.1.7)
Audit certificates report (E3 16.1.8)
Statistical methods interim analysis plan (E3 16.1.9)
Inter-laboratory standardisation methods quality assurance (E3
16.1.10)
Publications based on study (E3 16.1.11)
Publications referenced in report (E3 16.1.12)
Discontinued patients (E3 16.2.1)
Protocol deviations (E3 16.2.2)
Patients excluded from efficacy analysis (E3 16.2.3)
Demographic data (E3 16.2.4)
Compliance and drug concentration data (E3 16.2.5)
Individual efficacy response data (E3 16.2.6)
Adverse event listings (E3 16.2.7)
Listing individual laboratory measurements by patient (E3
16.2.8)
Case report forms (E3 16.3)
Site
[identifier]
Available on request
Data tabulation
Data tabulation
dataset legacy
Data tabulation dataset sdtm
Data tabulation data definition
Data listing dataset (E3 16.4)
Data listing dataset
Data listing data definition
Analysis datasets
Analysis dataset adam
Analysis dataset legacy
Analysis program
Analysis data definition
Annotated CRF
ECG
Image
Subject profiles
Safety report
Assay validation
Biomarkers
Data monitoring review committees
Device information
Diagnostic tests
Gene therapy
Patient reported outcomes
Pharmacodynamics
Pharmacogenomics
Pharmacokinetics
Quality of life
Stem cells
Abuse liability
Antibody
Healthcare utilization
Other data not specified
PK PD relationship
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Specialty report
Foreign clinical studies not under ind
5.3.1.2 Comparative BA and bioequivalence (BE) Study reports and
related information
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.1.3 In Vitro - in Vivo correlation Study reports and related
information
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.1.4 Reports of bioanalytical and analytical methods for
human studies
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.2 Reports of studies pertinent to pharmacokinetics using human
biomaterials
5.3.2.1 Plasma protein binding Study reports and related
information
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.2.2 Reports of hepatic metabolism and drug interaction studies
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.2.3 Reports of studies using other human biomaterials
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.3 Reports of human pharmacokinetic (PK) studies
5.3.3.1 Healthy subject PK and initial tolerability Study reports and
related information
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.3.2 Patient PK and initial tolerability Study reports and
related information
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.3.3 Intrinsic factor PK Study reports and related information
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.3.4 Extrinsic factor Study reports and related information
Study report [identification] and related information
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See example under bioavailability (BA) Study reports and related
information for headings
5.3.3.5 Population PK Study reports and related information
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.4 Reports of human pharmacodynamic (PD) studies
5.3.4.1 Healthy subject PD and PK/PD Study reports and related
information
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.4.2 Patient PD and PK/PD Study reports and related
information
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.5 Reports of efficacy and safety studies [Indication]
5.3.5.1 Study reports and related information of controlled clinical
studies pertinent to the claimed indication [type of control]
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
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5.3.5.2 Study reports and related information of uncontrolled
clinical studies
Study report [identification] and related information
See example under bioavailability (BA) Study reports and related
information for headings
5.3.5.3 Reports of analyses of data from more than one study
Study report [identification] and related information
Integrated analysis of safety
Iss
Analysis datasets
Analysis dataset adam
Analysis dataset legacy
Analysis program
Analysis data definition
Integrated analysis of efficacy
Ise
Analysis datasets
Analysis dataset adam
Analysis dataset legacy
Analysis program
Analysis data definition
5.3.5.4 Other Study reports and related information
Study report [identification] and related information
Antibacterial microbiology reports
Antibacterial
Special pathogens (e.g., fungi, parasites, mycobacteria) and immune
modulator reports
Special pathogen
Antiviral reports
Antiviral
BIMO
bimo
Human Factor
HF-validation-protocol
HF-validation-report
HF-validation-other
5.3.6 Reports of postmarketing experience
Postmarketing periodic adverse event drug experience report
description
5.4 Literature references
IND Mapping Section
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Appendix 1 – Mapping Section
IND
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
312.23(a)(1)
Cover sheet (Form FDA–1571)
1
1.1
**Forms form-type=1571
FDAAA
Certification of compliance:
Form FDA 3674
1
1.1
**Forms form-type=3674
BsUFA
Form FDA 3792: Biosimilar User
Fee Cover Sheet
1
1.1
**Forms form-type=3792
312.31(b)(1)
Statement of the nature and
purpose of the information
amendment
1
1.2
Cover letters
Change of address or corporate
name
NOTE: Includes DMF original
address or corporate name or
change in DMF address or
corporate name
1
1.3.1.1
Change of address or corporate name
Change in contact/agent
NOTE: Includes DMF original
contact/agent or change in DMF
contact/agent
1
1.3.1.2
Change in contact/agent
Change in ownership
1
1.3.1.3
Change in sponsor
312.52
Transfer of obligations to a
contract research organization
1
1.3.1.4
Transfer of obligation
312.22(d)
General principles of the IND
submission
1.4.1
Letter of authorization
312.23(b)
Written statement of
authorization for references
(copy of LOA received from
DMF holders - submitted by
BLA, NDA, or IND applicants)
1
1.4.2
Statement of right of reference
IND Mapping Section
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CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
312.23(b)
312.23(a)(3)(ii)
Information previously
submitted
1
1.4.4
Cross-reference to previously submitted
information
312.38
Withdrawal of an IND
1
1.5.1
Withdrawal of an IND
312.45(a)
Request for Inactive status
1
1.5.2
Inactivation request
312.45(d)
Request to resume clinical
investigation under an inactive
IND
1
1.5.3
Reactivation request
Reinstatement request
1
1.5.4
Reinstatement request
312.47
PDUFA Agreements
Meeting request
1
1.6.1
Meeting request
312.47
PDUFA Agreements
Meeting background material
1
1.6.2
Meeting background materials
312.47
PDUFA Agreements
Correspondence regarding a
meeting
1
1.6.3
Correspondence regarding meetings
FDAMA
Fast track designation request
1
1.7.1
Fast track designation request
FDAMA
Fast track designation
withdrawal request
1
1.7.2
Fast track designation withdrawal request
FDAMA
Rolling review request
1
1.7.3
Rolling review request
FDAMA
Correspondence regarding fast
track/rolling review
1
1.7.4
Correspondence regarding fast track/rolling
review
FDAMA
Special protocol assessment
request: clinical study
1
1.8.1
Clinical study
PDUFA Agreements
Special protocol assessment
request: carcinogenicity study
1
1.8.2
Carcinogenicity study
PDUFA Agreements
Special protocol assessment
request: stability study
1
1.8.3
Stability study
Animal efficacy study for
approval under the animal rule
1
1.8.4.
Animal efficacy study for approval under
the animal rule
PREA
312.47(b)(1)(iv)
Request for waiver of pediatric
studies
1
1.9.1
Request for waiver of pediatric studies
IND Mapping Section
Version 2.3.3
15
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
PREA
312.82
312.47(b)(1)(iv)
Request for deferral of pediatric
studies
1
1.9.2
Request for deferral of pediatric studies
BPCA
Proposed pediatric study request
and amendments
1
1.9.4
Proposed pediatric study request and
amendments
PREA
BPCA
Correspondence regarding
pediatric exclusivity or PREA
requirements
1
1.9.6
Other correspondence regarding pediatric
exclusivity or study plans
312.48
Scientific and medical disputes
1
1.10.1
Request for dispute resolution
312.48
Scientific and medical disputes
1
1.10.2
Correspondence related to dispute resolution
312.31
Information amendment:
Chemistry - information not
covered under Module 3
1
1.11.1
Quality information amendment
312.31
Information amendment:
Toxicology - information not
covered under Module 4
1
1.11.2
Nonclinical information amendment
312.31
Information amendment:
Clinical - information not
covered under Module 5
1
1.11.3
Clinical information amendment
312.31
Multiple Information
amendment
1
1.11.4
Multiple module information amendment
312.82(a)
Pre-IND correspondence
1
1.12.1
Pre-IND correspondence
312.8(b)
Charging for investigational
drugs under an IND
1
1.12.2
Request to charge for clinical trial
312.8(c)
Charging for investigational
drugs under an IND
1
1.12.3
Request to charge for expanded access
312.31(b)(3)
Request for comment on
information amendment
1
1.12.4
Request for comments and advice
312.41
Comment and advice on an IND
1
1.12.4
Request for comments and advice
312.10
Waivers (including PSUR
waiver)
1
1.12.5
Request for a waiver
IND Mapping Section
Version 2.3.3
16
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
312.54
Exception from informed
consent for research
1
1.12.6
Exception from informed consent for
emergency research
312.54
Public disclosure – exception
from informed consent for
research
1
1.12.7
Public disclosure statement for exception
from informed consent for emergency
research
312.54
IRB disapproval of exception
from informed consent for
research
1
1.12.8
Correspondence regarding exception from
informed consent for emergency research
312.31(a)(2)
Report regarding the
discontinuation of a clinical
investigation
1
1.12.9
Notification of discontinuation of clinical
trial
312.23(a)(7)(iv)(e)
Environmental analysis
requirements
1
1.12.14
Environmental analysis
316 Subpart C
Orphan Drug
1
1.12.17
Orphan drug designation
312.33(b)(6)
Annual Report: A list of
preclinical studies…
1
1.13.1
Summary of nonclinical studies
312.33(b)(5)
Annual Report: A brief
description of the drug’s
actions…
1
1.13.2
Summary of clinical pharmacology
information
312.33(b)(1)
Annual Report: A narrative or
tabular summary showing the
most frequent and most serious
adverse experiences by the body
system
1
1.13.3
Summary of safety information
312.33(b)(2)
Annual Report: A summary of
all IND safety reports…
1
1.13.3
Summary of safety information
312.33(b)(3)
Annual Report: A list of
subjects who died…
1
1.13.3
Summary of safety information
312.33(b)(4)
Annual Report: A list of
subjects who dropped out…
1
1.13.3
Summary of safety information
IND Mapping Section
Version 2.3.3
17
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
312.33(b)(7)
Annual Report: A summary of
any significant manufacturing
changes…
1
1.13.5
Summary of manufacturing changes
312.33(b)(7)
Annual Report: A summary of
any significant microbiological
changes…
1
1.13.6
Summary of microbiological changes
312.33(a)
Annual report individual study
information
1
1.13.8
Individual study information
312.33(c)
Annual Report: A description of
the general investigational
plan…
1
1.13.9
General investigational plan
312.33(f)
Annual Report: A brief
summary of significant foreign
marketing developments…
1
1.13.10
Foreign marketing
312.33(g)
Annual Report: Log of
outstanding
business…(optional)
1
1.13.14
Log of outstanding regulatory business
Development safety update
report (DSUR)
1
1.13.15
Development safety update report (DSUR)
312.6
Draft labeling text
1
1.14.1.3
Draft labeling text
Label comprehension studies
1
1.14.1.4
Label comprehension studies
312.23(a)(5)
Investigator brochure
1
1.14.4.1
Investigator brochure
312.33(d)
Annual Report: Investigators
brochure…
1
1.14.4.1
Investigator brochure
312.23(a)(7)(iv)(d)
Labeling
1
1.14.4.2
Investigational drug labeling
Foreign labeling
1
1.14.5
Foreign labeling
Proprietary names
1
1.18
Proprietary names
Project BioShield Act
of 2004
Emergency Use Authorization
1
1.19
Pre-EUA and EUA
312.23(a)(3)(iv)
A brief description of the overall
plan…
1
1.20
General investigational plan for initial IND
IND Mapping Section
Version 2.3.3
18
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
312.23(a)(3)(i)
Introductory statement
2
2.2
Introduction to summary
312.23(a)(7)(a), (b)
and (c)
Chemistry, manufacturing, and
controls
2
2.3
Quality overall summary
312.23(a)(8)
Pharmacology and toxicology
information
2
2.4
Nonclinical overview
312.23(a)(9)
Previous human experience
2
2.5
Clinical overview
312.23(a)(3)(ii-iii)
Introductory statement
2
2.5
Clinical overall summary
312.23(a)(8)
Pharmacology and toxicology
information
2
2.6
Nonclinical written and tabulated summaries
[use appropriate sections]
312.23(a)(9)
Previous human experience
2
2.7
Clinical summary [use appropriate sections]
312.23(a)(10)(i)
Drug dependence and abuse
2
2.7.4
Summary of Clinical Safety
312.23(a)(8)
Pharmacology and toxicology
information
4
4.2
Study reports [use appropriate sections]
312.23(a)(9)
Previous human experience
5
5.3
Clinical study reports and related
information [use appropriate sections]
312.30(a)
New protocol
5
5.3
Protocol [under specific study]
312.30(b)
Changes in protocol
5
5.3
Protocol [under specific study]
312.30(c)
New investigator
5
5.3
List and description of investigators and
sites [under specific study]
312.23(a)(6)
Protocol
5
5.3
*Protocol [under specific study]
312.32
IND safety reports
5
5.3
*IND safety report [under specific study]
312.33(e)
Annual Report: A description of
any significant Phase 1 protocol
modifications made during the
previous years and….
5
5.3
*Protocol [under the specific study]
312.320
Treatment protocol
5
5.3
*Protocol [under specific study]
312.120(b)(1)
Foreign clinical studies not
conducted under the IND:
Investigator’s qualification
5
5.3
*List and description of investigators and
sites [under specific study]
IND Mapping Section
Version 2.3.3
19
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
312.120(b)(2)
Foreign clinical studies not
conducted under the IND:
Research facility
5
5.3
*List and description of investigators and
sites [under specific study]
312.120(b)(3)
Foreign clinical studies not
conducted under the IND:
Detailed summary
5
5.3
Use appropriate sections [under specific
study]
312.120(a)(1)
Foreign clinical studies not
conducted under the IND:
Conformance with ethical
principles
5
5.3
*List of IECs or IRBs and consent forms
[under specific study]
312.23(a)(11)
Relevant information
1, 2, 3, 4,
or 5
As needed
Use appropriate sections
312.23(c)
Material in a foreign language
(English translations)
1, 2, 3, 4,
or 5
As needed
Use appropriate sections
312.23(a)(10)(iv)
Other information
2, 3, 4, or 5
As needed
Use appropriate sections
312.23(a)(10)(ii)
Radioactive drugs
2, 4, or 5
As needed
Use appropriate sections
312.23(a)(7)(a), (b)
and (c)
Chemistry, manufacturing and
controls
3
As needed
Quality [use appropriate sections]
312.31(a)(1),
Information amendment:
Chemistry
3
As needed
Use appropriate sections
312.120(b)(4)
Foreign clinical studies not
conducted under the IND: A
description of the drug
substance and drug product
3
As needed
Use appropriate sections
312.31
Information amendment:
Toxicology
4
As needed
Use appropriate sections
312.31
Information amendment:
Clinical
5
As needed
Use appropriate sections
312.23(a)(2)
Table of contents
N/A
N/A
N/A
Version 2.3.3
20
NDA and BLA Mapping Section
NDA and BLA
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
314.50(a)
601.2
Application Form FDA 356h
1
1.1
**Forms form-type=356h
PDUFA
User fee cover sheet: Form FDA
3397
1
1.1
**Forms form-type=3397
BsUFA
Form FDA 3792: Biosimilar User
Fee Cover Sheet
1
1.1
**Forms form-type=3392
314.81(b)(2)
Annual report transmittal: Form
FDA 2252
1
1.1
**Forms form-type=2252
314.81(b)(3)(i)
601.12(f)(4)
Transmittal of advertisements
and promotional labeling: Form
FDA 2253
1
1.1
**Forms form-type=2253
601.12 (f)
Transmittal of labels and
circulars: Form FDA 2567
1
1.1
**Forms form-type=2567
Cover letters
1
1.2
Cover letters
Change of address or corporate
name
NOTE: Includes DMF original
address or corporate name or
change in DMF address or
corporate name
1
1.3.1.1
Change of address or corporate name
Change in contact/agent
NOTE: Includes DMF original
contact/agent or change in DMF
contact/agent
1
1.3.1.2
Change in contact/agent
314.50(d)(5)(x)
Transfer of obligations to CRO
1
1.3.1.4
Transfer of obligation
314.72
601.4
Change in ownership of an
application
1
1.3.1.5
Change in ownership of an application or
reissuance of license
314.50(d)(1)(v)
Field copy certification
1
1.3.2
Field copy certification
GDEA
Debarment certification
1
1.3.3
Debarment certification
Version 2.3.3
21
NDA and BLA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
314.50(k)
601.2(a)
Financial certification and
disclosure statement (Form FDA
3454 and Form FDA 3455)
1
1.3.4
Financial certification and disclosure
314.50(h)
314.53(e)
Patent Information (Form FDA
3542a and Form FDA 3542)
1
1.3.5.1
Patent information
314.50(i)
314.52(e)
Patent certification
1
1.3.5.2
Patent certification
314.50(j)
Claimed exclusivity
1
1.3.5.3
Exclusivity claim
FDAAA
Tropical disease priority review
voucher
1
1.3.6
Tropical disease priority review voucher
314.420(d)
Incorporating DMF information
by reference (authorization from
DMF holder)
1
1.4.1
Letter of authorization
314.50(g)(1)
Written statement of
authorization for references
(copy of LOA received from
DMF holders - submitted by
BLA, NDA, or IND applicants )
1
1.4.2
Statement of right of reference
314.420(d)
List of authorized persons to
incorporate by reference
1
1.4.3
List of authorized persons to incorporate by
reference
314.50(g)(1)
Reference to information
previously submitted
1
1.4.4
Cross-reference to previously submitted
information
314.65
Withdrawal of an unapproved
application
1
1.5.5
Withdrawal of an unapproved NDA, ANDA
or Supplement
314.50
Withdrawal of listed drug
1
1.5.6
Withdrawal of listed drug
314.150(c)
Withdrawal of approval
1
1.5.7
Withdrawal of approval of an application or
revocation of license
314.150
601.5
Withdrawal of approval by the
FDA
1
1.5.7
Withdrawal of approval of an application or
revocation of license
314.102
Communications:
Meetings
1
1.6.1
Meeting request
Version 2.3.3
22
NDA and BLA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
314.102
Communications:
Meetings
1
1.6.2
Meeting background materials
314.102
Communications:
Meetings
1
1.6.3
Correspondence regarding meetings
FDAMA
Fast track designation request
1
1.7.1
Fast track designation request
FDAMA
Fast track designation
withdrawal request
1
1.7.2
Fast track designation withdrawal request
FDAMA
Rolling review request
1
1.7.3
Rolling review request
FDAMA
Correspondence regarding fast
track/rolling review
1
1.7.4
Correspondence regarding fast track/rolling
review
PREA
314.55(c)
601.27(c)
Request for waiver of pediatric
studies
1
1.9.1
Request for waiver of pediatric studies
PREA
314.55(b)
601.27(b)
Request for deferral of pediatric
studies
1
1.9.2
Request for deferral of pediatric studies
BPCA
Request for pediatric exclusivity
determination/Form FDA 3437
1
1.9.3
Request for pediatric exclusivity
determination
BPCA
Proposed pediatric study request
and amendments
1
1.9.4
Proposed pediatric study request and
amendments
PREA
BPCA
Correspondence regarding
pediatric exclusivity or PREA
requirements
1
1.9.6
Other correspondence regarding pediatric
exclusivity or study plans
314.103(c)
Scientific and medical disputes
1
1.10.1
Request for dispute resolution
314.103(c)
Scientific and medical disputes
1
1.10.2
Correspondence related to dispute resolution
314.60
Amendment to an unapproved
application: Chemistry
(information not covered under
Module 3)
1
1.11.1
Quality information amendment
314.60
Amendment to an unapproved
application: Toxicology
1
1.11.2
Nonclinical information amendment
Version 2.3.3
23
NDA and BLA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
(information not covered under
Module 4)
314.60
Amendment to an unapproved
application: Clinical (information
not covered under Module 5)
1
1.11.3
Clinical information amendment
314.60
Multiple information
amendment:
1
1.11.4
Multiple module information amendment
Request for comment and advice
1
1.12.4
Request for comments and advice
314.90
600.90
Waivers (including PSUR
waiver)
1
1.12.5
Request for a waiver
GDEA
Generic drug enforcement act
statement
1
1.12.10
Generic drug enforcement act statement
314.50(d)(1)(iii)
601.2
Environmental impact
1
1.12.14
Environmental analysis
320.22 (a)
Request for waiver of in vivo
bioavailability studies
1
1.12.15
Request for waiver of in vivo bioavailability
studies
314.81(b)(1)
Field alert reports
1
1.12.16
Field alert reports
316 Subpart C
Orphan drug
1
1.12.17
Orphan drug designation
314.81(b)(2)(i)
601.12(d)
Annual Report: Summary
1
1.13.1
Summary of nonclinical studies
314.81(b)(2)(i)
601.12(d)
Annual Report: Summary
1
1.13.2
Summary of clinical pharmacology
information
314.81(b)(2)(i)
601.12(d)
Annual Report: Summary
1
1.13.3
Summary of safety information
314.81(b)(2)(i)
601.12(f)(3)
Annual Report: Summary
1
1.13.4
Summary of labeling changes
314.81(b)(2)(i)
601.12(d)
Annual Report: Summary
1
1.13.5
Summary of manufacturing changes
314.81(b)(2)(i)
601.12(d)
Annual Report: Summary
1
1.13.6
Summary of microbiological changes
314.81(b)(2)(i)
Annual Report: Summary
1
1.13.7
Summary of other significant new
Version 2.3.3
24
NDA and BLA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
601.12(d)
information
314.81(b)(2)(ii)
Annual Report: Distribution data
1
1.13.11
Distribution data
314.81(b)(2)(vii)
601.70
Annual Report: Status report of
clinical and nonclinical
toxicology postmarketing study
commitments
1
1.13.12
Status of postmarketing study commitments
and requirements
314.81(b)(2)(viii)
Status report of other (chemistry,
manufacturing, controls)
postmarketing study
commitments
1
1.13.13
Status of other postmarketing studies and
requirements
314.81(b)(2)(ix)
Annual Report: Log of
outstanding regulatory business
1
1.13.14
Log of outstanding regulatory business
314.50(e)(2)(ii)
601.14
Copies of the labeling and all
labeling for the drug product
1
1.14
Use appropriate sections
314.81(b)(2)(iii)
601.14(f)(3)
Annual Report: Labeling
1
1.14
Use appropriate sections
314.50
601.14
Draft carton and container labels
1
1.14.1.1
Draft carton and container labels
314.50(c)(2)(i)
The proposed text of the labeling
with annotations
1
1.14.1.2
Annotated draft labeling text
314.50(e)(2)(ii)
601.2 601.14
Draft labeling text
1
1.14.1.3
Draft labeling text
Label comprehension studies
1
1.14.1.4
Label comprehension studies
Labeling history
1
1.14.1.5
Labeling history
314.50(e)(2)(ii)
601.2
Final carton or container labels
1
1.14.2.1
Final carton or container labels
314.50(e)(2)(ii)
601.2; 601.14
Final package insert (package
inserts, patient information,
medication guides)
1
1.14.2.2
Final package insert (package inserts, patient
information, medication guides)
314.50(e)(2)(ii)
601.2; 601.14
Final labeling text
1
1.14.2.3
Final labeling text
Version 2.3.3
25
NDA and BLA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
Foreign labeling
1
1.14.5
Foreign labeling
314.81(b)(3)(i)
601.12(f)(4)
Product labeling for 2253
submissions (if applicable)
1
1.14.6
Product labeling for 2253 submissions
314.81(b)(3)(i)
601.12(f)(4)
314.550
601.45
202.1(j)(4)
314.640
601.94
202.1
Regulations related to
promotional materials [use
appropriate sections]
1
1.15
Promotional material **[promotional-
material-audience-type]
202.1(j)(4)
Request for advisory comments
on launch materials
1
1.15.1.1
Request for advisory comments on launch
materials
202.1(j)(4)
Request for advisory comments
on non-launch materials
1
1.15.1.2
Request for advisory comments on non-
launch materials
314.550
601.45
Presubmission of launch
promotional materials for
accelerated approval of products
for serious or life-threatening
illnesses
1
1.15.1.3
Presubmission of launch promotional
materials for accelerated approval products
314.640
601.94
Presubmission of launch
promotional materials for
products approved when human
efficacy studies are not ethical or
feasible
1
1.15.1.3
Presubmission of launch promotional
materials for accelerated approval products
314.550
601.45
Presubmission of non-launch
promotional materials for
accelerated approval of products
for serious or life-threatening
illnesses
1
1.15.1.4
Presubmission of non-launch promotional
materials for accelerated approval products
314.640
Presubmission of non-launch
1
1.15.1.4
Presubmission of non-launch promotional
Version 2.3.3
26
NDA and BLA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
601.94
promotional materials for
products approved when human
efficacy studies are not ethical or
feasible
materials for accelerated approval products
202.1
Section 503C of the
Food, Drug, and
Cosmetic Act
Pre-dissemination review of
television ads
1
1.15.1.5
Pre-dissemination review of television ads
202.1
Response to untitled letter or
warning letter
1
1.15.1.6
Response to untitled letter or warning letter
202.1
Response to information request
1
1.15.1.7
Response to information request
202.1
314.81(b)(3)(i)
601.12(f)(4)
202.1(j)(4)
314.550
601.45
314.640
601.94
Correspondence accompanying
materials previously missing or
rejected
1
1.15.1.8
Correspondence accompanying materials
previously missing or rejected
202.1
314.81(b)(3)(i)
601.12(f)(4)
202.1(j)(4)
314.550
601.45
314.640
601.94
Withdrawal request
1
1.15.1.9
Withdrawal request
202.1
202.1(j)(4)
314.550
601.45
Submission of annotated
references
1
1.15.1.10
Submission of annotated references
Version 2.3.3
27
NDA and BLA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
314.640
601.94
202.1
General correspondence
1
1.15.1.11
General correspondence
314.81(b)(3)(i)
601.12(f)(4)
202.1(j)(4)
314.550
601.45
314.640
601.94
202.1
Regulations related to
promotional materials [use
appropriate sections]
1
1.15.2
Materials ** [promotional-material-doc-
type]
314.81(b)(3)(i)
601.12(f)(4)
202.1(j)(4)
314.550
601.45
314.640
601.94
202.1
Regulations related to
promotional materials [use
appropriate sections]
1
1.15.2.1
Material **[promotional-material-type,
material-id, issue-date]
202.1
314.81(b)(3)(i)
601.12(f)(4)
202.1(j)(4)
314.550
601.45
314.640
601.94
Clean version
1
1.15.2.1.1
Clean version
202.1(j)(4)
314.550
601.45
314.640
Annotated version
1
1.15.2.1.2
Annotated version
Version 2.3.3
28
NDA and BLA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
601.94
202.1
202.1(j)(4)
314.550
601.45
314.640
601.94
202.1
Annotated labeling version
1
1.15.2.1.3
Annotated labeling version
202.1(j)(4)
314.550
601.45
314.640
601.94
202.1
Annotated references
1
1.15.2.1.4
Annotated references
FDAAA 505-1
[355-1]
Risk evaluation and mitigation
strategies (REMS)
1
1.16
Use the appropriate sections
FDAAA
Correspondence regarding
postmarketing commitments
1
1.17.1
Correspondence regarding postmarketing
commitments
FDAAA
Correspondence regarding
postmarketing requirements
1
1.17.2
Correspondence regarding postmarketing
requirements
Proprietary names
1
1.18
Proprietary names
314.50(d)(5)(viii)
An integrated summary of the
benefits and risks
2
2.5
Use appropriate sections
314.50(c)(2)(ii) to
(ix)
Summaries…
2
As needed
Use the appropriate sections
314.50(d)(7)
Pediatric use section
2 and 5
As needed
Use appropriate sections
314.50(d)(1)(i) and
(ii)
Chemistry, manufacturing and
controls
3
As needed
Use the appropriate sections
314.50(e)(2)(i)
Analytical methods
3
As needed
Use appropriate sections
Version 2.3.3
29
NDA and BLA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
314.60
Amendment to an unapproved
application: Chemistry
3
As needed
Use appropriate sections
600.81
Distribution reports
3
3.2.R
Regional Information
314.81(b)(2)(iv)
Annual Report: Chemistry,
manufacturing, and controls
3
As needed
Use appropriate sections
314.50(d)(2)
Nonclinical pharmacological and
toxicology section
4
As needed
Use appropriate sections
314.81(b)(2)(v)
Annual Report: Nonclinical
laboratory studies
4
As needed
Use appropriate sections
314.60
Amendment to an unapproved
application: Toxicology
4
As needed
Use appropriate sections
314.50(d)(5)(ix)
Statement of compliance with
informed consent
5
5.3
*List of IECs or IRBs and consent forms
[under specific study]
314.50(d)(5)(xi)
Audited studies
5
5.3
*Audit certificates and reports [under
specific study]
314.50(d)(6)(i) and
(ii)
Description of statistical analysis
5
5.3
*Documentation of statistical methods and
interim analysis plans [under specific study]
314.50(f)(1)
Case report tabulations
5
5.3
*Case report tabulations [use the appropriate
sections under the specific study]
314.50(f)(2)
Case report forms
5
5.3
*Case report forms [under the appropriate
site and specific study]
314.50(d)(5)(i) to (iv)
Clinical data section
5
5.3
Use appropriate sections
314.50(d)(3)
Human pharmacokinetics and
bioavailability sections
5
5.3
Use appropriate sections
314.50(d)(5)(vii)
Potential for abuse
5
5.3
Use appropriate sections
314.50(d)(5)(v)
An integrated summary of
efficacy
5
5.3.5.3
Reports of analysis of data from more than
one study [Use appropriate sections in
integrated summary of efficacy STF]
314.50(d)(5)(vi)(a)
An integrated summary of safety
5
5.3.5.3
Reports of analysis of data from more than
one study [Use appropriate sections in
integrated summary of safety STF]
Version 2.3.3
30
NDA and BLA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
314.50(d)(5)(vi)(b)
Safety Update
5
5.3.5
Reports of analysis of data from more than
one study [Use appropriate sections in
integrated summary of safety STF]
314.50(d)(4)
Microbiology
5
5.3.5.4
Other study reports and related information
[Use appropriate sections in microbiology
STF]
314.80(c)(2)(ii)(a)
314.80(c)(2)(ii)(c)
600.80(c)(20(ii)(A)
600.80(c)(2)(ii)(C)
Periodic adverse drug experience
– narrative summary and history
of actions
5
5.3.6
Postmarketing periodic adverse event drug
experience report description
314.70 and 314.71
601.12
Supplements and other changes
to approved applications
1, 2, 3, 4, 5
As needed
Use the appropriate sections
314.420(a)
Drug master files
1, 2, 3, 4, 5
As needed
Use appropriate sections
314.60
Amendment to an unapproved
application: Clinical
5
As needed
Use appropriate sections
314.81(b)(2)(vi)
Annual Report: Clinical data
5
As needed
Use appropriate sections
315.50(b)
Index
N/A
N/A
N/A
Version 2.3.3
31
ANDA Mapping Section
ANDA
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
314.94(a)(1)
Application Form FDA 356h
1
1.1
**Forms form-type=356h
GDUFA
Form FDA 3794: Generic Drug
User Fee Cover Sheet
1
1.1
**Forms form-type=3794
FDAAA
Certification of compliance:
Form FDA 3674
1
1.1
**Forms form-type=3674
Transmittal of labels and
circulars: Form FDA 2567
1
1.1
**Forms form-type=2567
314.81(b)(3)(i)
Transmittal of advertisements
and promotional labeling: Form
FDA 2253
1
1.1
**Forms form-type=2253
Cover letters
1
1.2
Cover letters
Change of address or corporate
name
NOTE: Includes DMF original
address or corporate name or
change in DMF address or
corporate name
1
1.3.1.1
Change of address or corporate name
Change in contact/agent
NOTE: Includes DMF original
contact/agent or change in DMF
contact/agent
1
1.3.1.2
Change in contact/agent
314.72
Change in ownership of an
application
1
1.3.1.5
Change in ownership of an application
314.50(d)(1)(v)
Field copy certification
1
1.3.2
Field copy certification
Generic Drug
Enforcement Act
(GDEA)
Debarment certification
1
1.3.3
Debarment certification
314.94(13)
Financial certification and
disclosure (Form FDA 3454 and
Form FDA 3455)
1
1.3.4
Financial certification and disclosure
Version 2.3.3
32
ANDA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
314.50(h)
314.53(e)
Patent information (Form FDA
3542a and Form FDA 3542)
1
1.3.5.1
Patent information
314.94(12)
Patent certification
1
1.3.5.2
Patent certification
314.95
Notice of certification of
nonvalidity or noninfringement
of patent
1
1.3.5.3
Exclusivity claim
314.420(d)
Incorporating DMF information
by reference (authorization from
DMF holder)
1
1.4.1
Letter of authorization
314.50(g)(1)
Written statement of
authorization for references
(copy of LOA received from
DMF holders - submitted by
BLA, NDA, or IND applicants )
1
1.4.2
Statement of right of reference
314.420(d)
List of authorized persons to
incorporate by reference
1
1.4.3
List of authorized persons to incorporate
by reference
314.94(11)
Reference to information
previously submitted
1
1.4.4
Cross-reference to previously submitted
information
314.65
Withdrawal of an unapproved
application
1
1.5.5
Withdrawal of an unapproved BLA, NDA,
ANDA or Supplement
314.150
Withdrawal of listed drug
1
1.5.6
Withdrawal of listed drug
314.150(c)
Request for withdrawal of
approval
1
1.5.7
Withdrawal of approval of an application
or revocation of license
314.102
Communications: meetings
1
1.6.1
Meeting request
314.102
Communications: meetings
1
1.6.2
Meeting background materials
314.102
Communications: meetings
1
1.6.3
Correspondence regarding meetings
314.103(c)
Scientific and medical disputes
1
1.10.1
Request for dispute resolution
314.103(c)
Scientific and medical disputes
1
1.10.2
Correspondence related to dispute
resolution
314.96
Amendment to an unapproved
application: Chemistry
1
1.11.1
Quality information amendment
Version 2.3.3
33
ANDA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
(information not fitting under
Module 3)
314.98
Amendment to an unapproved
application: Toxicology
(information not covered under
Module 4)
1
1.11.2
Nonclinical information amendment
314.96
Amendment to an unapproved
application: Clinical
(information not fitting under
Module 5)
1
1.11.3
Clinical information amendment
314.96
Multiple information
amendment:
1
1.11.4
Multiple module information amendment
Request for comment and advice
1
1.12.4
Request for comments and advice
GDEA
Generic drug enforcement act
statement
1
1.12.10
Generic drug enforcement act statement
314.94(a)(3)
Basis for abbreviated new drug
application submission
1
1.12.11
ANDA basis for submission statement
314.94(a)(4)
Conditions for use
1
1.12.11
ANDA basis for submission statement
314.94(a)(5)
Active ingredient
1
1.12.12
Comparison of generic drug and reference
listed drug
314.94(a)(6)
Route of administration, dosage
form, and strength
1
1.12.12
Comparison of generic drug and reference
listed drug
25.15(d)
Environmental impact analysis
statement (if applicable)
1
1.12.14
Environmental analysis
320.22 (a)
Request for waiver of in vivo
bioavailability studies
1
1.12.15
Request for waiver of in-vivo
bioavailability studies
314.81(b)(i)(ii)
Field alert reports
1
1.12.16
Field alert reports
314.81(b)(2)(i)
Annual Report: Summary
1
1.13.1
Summary of nonclinical studies
314.81(b)(2)(i)
Annual Report: Summary
1
1.13.2
Summary of clinical pharmacology
information
314.81(b)(2)(i)
Annual Report: Summary
1
1.13.3
Summary of safety information
Version 2.3.3
34
ANDA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
314.81(b)(2)(i)
Annual Report: Summary
1
1.13.4
Summary of labeling changes
314.81(b)(2)(i)
Annual Report: Summary
1
1.13.5
Summary of manufacturing changes
314.81(b)(2)(i)
Annual Report: Summary
1
1.13.6
Summary of microbiological changes
314.81(b)(2)(i)
Annual Report: Summary
1
1.13.7
Summary of other significant new
information
314.81(b)(2)(ii)
Annual Report: Distribution data
1
1.13.11
Distribution data
314.81(b)(2)(vii)
Annual Report: Status report of
clinical and nonclinical
toxicology postmarketing study
commitments
1
1.13.12
Status of postmarketing study
commitments and requirements
314.81(b)(2)(viii)
Status report of other (chemistry,
manufacturing, controls)
postmarketing study
commitments
1
1.13.13
Status of other postmarketing studies and
requirements
314.81(b)(2)(ix)
Annual Report: Log of
outstanding regulatory business
1
1.13.14
Log of outstanding regulatory business
314.94(a)(8)(ii)
Copies of proposed labeling
[Use appropriate sections]
1
1.14.1
Draft labeling
314. 94(a)(8)(ii)
Draft carton and container labels
1
1.14.1.1
Draft carton and container labels
314.50(c)(2)(i)
The proposed text of the labeling
with annotations
1
1.14.1.2
Annotated draft labeling text
314.94(a)(8)(ii)
Draft labeling text
1
1.14.1.3
Draft labeling text
314.94(a)(8)(ii)
Final carton or container labels
1
1.14.2.1
Final carton or container labels
314.94(a)(8)(ii)
Final package insert (package
inserts, patient information,
medication guides)
1
1.14.2.2
Final package insert (package inserts,
patient information, medication guides)
314.94(a)(8)(ii)
Final labeling text
1
1.14.2.3
Final labeling text
314.94(a)(8)(iii)
Statement of proposed labeling
1
1.14.3.1
Annotated comparison with listed drug
314.94(a)(8)(iv)
Comparison of approved and
proposed labeling
1
1.14.3.1
Annotated comparison with listed drug
314.94(a)(8)(i)
Listed drug labeling
1
1.14.3.2
Approved labeling text for listed drug
Version 2.3.3
35
ANDA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
314.94(a)(8)(i)
Labeling text for reference listed
drug
1
1.14.3.3
Labeling text for reference listed drug
314.81(b)(3)(i)
Product labeling for 2253
submissions (if applicable)
1
1.14.6
Product labeling for 2253 submissions
202.1
314.81(b)(3)(i)
202.1(j)(4)
314.550
314.640
Regulations related to
promotional materials [use
appropriate sections]
1
1.15
Promotional material **[attribute =
promotional-material-audience-type]
202.1
202.1(j)(4)
Request for advisory comments
on launch materials
1
1.15.1.1
Request for advisory comments on launch
materials
202.1
202.1(j)(4)
Request for advisory comments
on non-launch materials
1
1.15.1.2
Request for advisory comments on non-
launch materials
202.1
314.550
Presubmission of launch
promotional materials for
accelerated approval products
1
1.15.1.3
Presubmission of launch promotional
materials for accelerated approval products
202.1
314.640
Presubmission of launch
promotional materials for
products approved when human
efficacy studies are not ethical or
feasible
1
1.15.1.3
Presubmission of launch promotional
materials for accelerated approval products
202.1
314.550
Presubmission of non-launch
promotional materials for
accelerated approval products
1
1.15.1.4
Presubmission of non-launch promotional
materials for accelerated approval products
314.640
Presubmission of non-launch
promotional materials for
products approved when human
efficacy studies are not ethical or
feasible
1
1.15.1.4
Presubmission of non-launch promotional
materials for accelerated approval products
Version 2.3.3
36
ANDA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
202.1
Section 503C of
the Federal Food,
Drug, and
Cosmetic Act
Pre-dissemination review of
television ads
1
1.15.1.5
Pre-dissemination review of television ads
202.1
Response to untitled letter or
warning letter
1
1.15.1.6
Response to untitled letter or warning letter
202.1
Response to information request
1
1.15.1.7
Response to information request
202.1
314.81(b)(3)(i)
202.1(j)(4)
314.550
314.640
Correspondence accompanying
materials previously missing or
rejected
1
1.15.1.8
Correspondence accompanying materials
previously missing or rejected
202.1
314.81(b)(3)(i)
202.1(j)(4)
314.550
314.640
Withdrawal request
1
1.15.1.9
Withdrawal request
202.1
202.1(j)(4)
314.550
314.640
Submission of annotated
references
1
1.15.1.10
Submission of annotated references
202.1
General correspondence
1
1.15.1.11
General correspondence
202.1
314.81(b)(3)(i)
202.1(j)(4)
314.550
314.640
Regulations related to
submission of promotional
materials [use appropriate
sections]
1
1.15.2
Materials **[attribute = promotional-
material-doc-type]
202.1
314.81(b)(3)(i)
202.1(j)(4)
314.550
Regulations related to
promotional materials [use
appropriate sections]
1
1.15.2.1
Material **[attributes =promotional-
material-type, material-id, issue-date]
Version 2.3.3
37
ANDA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
314.640
202.1
314.81(b)(3)(i)
202.1(j)(4)
314.550
314.640
Clean version
1
1.15.2.1.1
Clean version
202.1
202.1(j)(4)
314.550
314.640
Annotated version
1
1.15.2.1.2
Annotated version
202.1
202.1(j)(4)
314.550
314.640
Annotated labeling version
1
1.15.2.1.3
Annotated labeling version
202.1
202.1(j)(4)
314.550
314.640
Annotated references
1
1.15.2.1.4
Annotated references
FDAAA 505-1
[355-1]
Risk evaluation and mitigation
strategies (REMS)
1
1.16
Use the appropriate sections
FDAAA
Correspondence regarding
postmarketing commitments
1
1.17.1
Correspondence regarding postmarketing
commitments
FDAAA
Correspondence regarding
postmarketing requirements
1
1.17.2
Correspondence regarding postmarketing
requirements
314.420(a)
Drug master files
1, 2, 3, 4, 5
As needed
Use appropriate sections
314.96
Amendment to an unapproved
application: Chemistry
3
As needed
Use appropriate sections
314.94(9)
Chemistry, manufacturing, and
control
3
As needed
Use appropriate sections
314.94(a)(7)
Bioequivalence
5
5.3
Use appropriate sections
314.96
Amendment to an unapproved
5
As needed
Use appropriate sections
Version 2.3.3
38
ANDA Mapping Section
CFR Citation/Source
CTD /*STF Heading/**Attribute(s)
NUMBER
TITLE
MODULE
NUMBER
TITLE
application: Clinical
314.94(a)(2)
Table of Contents
N/A
N/A
N/A
Version 2.3.3
39
Appendix 2 – Module 1 Summary of Changes
A. Module 1 Summary of Changes (02/07/2014, version 2.3)
Module
Section
Old Title
New Title
1.15.1.5
Promotional materials submitted pursuant to section
503B
Pre-dissemination review of television ads
B. Module 1 Summary of Changes (08/23/2013, version 2.2)
Module
Section
Old Title
New Title
1.15.2.1
Material <attribute = [promotional-material-type]>
1.15.2.1 Material [attributes=promotional-material-type,
material-id, issue-date]
C. Module 1 Summary of Changes (11/1/2012, version 2.1)
Module
Section
Old Title
New Title
1.16
Risk evaluation and mitigation strategies (REMS)
Risk Management Plan
1.16.1
N/A
Risk Management (Non-REMS)
1.16.2
N/A
Risk Evaluation and Mitigation Strategy (REMS)
1.16.2.1
N/A
Final REMS
1.16.2.2
N/A
Draft REMS
1.16.2.3
N/A
REMS Assessment
1.16.2.4
N/A
REMS Assessment Methodology
1.16.2.5
N/A
REMS Correspondence
1.16.2.6
N/A
REMS Modification History
Version 2.3.3
40
D. Module 1 Summary of Changes (6/1/2012, version 2.0)
Module
Section
Old Title
New Title
1.1
Forms and form type e.g.
1.1.1 Application form: FDA form 1571
1.1.2 Application form: FDA form 356h
1.1.3 User fee cover sheet: FDA form 3397
1.1.4 Annual report transmittal: FDA form 2252
1.1.5 Advertisements and promotional labeling
transmittal: FDA form 2253
1.1.6 Transmittal of Labels and Circulars: FDA form
2567
Forms
Form ** [attribute = form-type]
1.3.1.5
Change in ownership of an application
Change in ownership of an application or reissuance of
license
1.3.5.3
Exclusivity request
Exclusivity claim
1.3.6
N/A
Tropical disease priority review voucher
1.4.4
Cross reference to other applications
Cross-reference to previously submitted information
1.5.1
Withdrawal request
Withdrawal of an IND
1.5.5
Withdrawal of an unapproved NDA
Withdrawal of an unapproved BLA, NDA, ANDA, or
supplement
1.5.7
Request for withdrawal of application approval
Withdrawal of approval of an application or revocation of
license
1.7.4
N/A
Correspondence regarding fast track/rolling review
1.8.4.
N/A
Animal efficacy study for approval under the animal rule
1.9.5
Proposal for written agreement
No longer applicable
1.11.2
Safety information amendment
Nonclinical information amendment
1.11.3
Efficacy information amendment
Clinical information amendment
1.11.4
N/A
Multiple module information amendment
1.12.2
Request to charge
Request to charge for clinical trial
1.12.3
Notification of charging under treatment IND
Request to charge for expanded access
Version 2.3.3
41
Module
Section
Old Title
New Title
1.12.6
Exception from informed consent for research
Exception from informed consent for emergency research
1.12.7
Public disclosure statement for exception from
informed consent for research
Public disclosure statement for exception from informed
consent for emergency research
1.12.8
Correspondence regarding exception from informed
consent for research
Correspondence regarding exception from informed consent
for emergency research
1.12.11
Basis for submission statement
ANDA basis for submission statement
1.12.17
N/A
Orphan drug designation
1.13.12
Status of postmarketing study commitments
Status of postmarketing study commitments and
requirements
1.13.13
Status of other postmarketing studies
Status of other postmarketing studies and requirements
1.13.15
N/A
Development safety update report (DSUR)
1.14.6
N/A
Product labeling for 2253 submissions
1.15
Promotional material
Promotional material <attribute = [promotional-material-
audience-type]>
1.15.1
N/A
Correspondence relating to promotional materials
1.15.1.1
N/A
Request for advisory comments on launch materials
1.15.1.2
N/A
Request for advisory comments on non-launch materials
1.15.1.3
N/A
Presubmission of launch promotional materials for
accelerated approval products
1.15.1.4
N/A
Presubmission of non-launch promotional materials for
accelerated approval products
1.15.1.5
N/A
Promotional materials submitted pursuant to section 503B
1.15.1.6
N/A
Response to untitled letter or warning letter
1.15.1.7
N/A
Response to information request
1.15.1.8
N/A
Correspondence accompanying materials previously missing
or rejected
1.15.1.9
N/A
Withdrawal request
1.15.1.10
N/A
Submission of annotated references
1.15.1.11
N/A
General correspondence
1.15.2
N/A
Materials <attribute = [promotional-material-doc-type]>
Version 2.3.3
42
Module
Section
Old Title
New Title
1.15.2.1
N/A
Material <attribute = [promotional-material-type]>
1.15.2.1.1
N/A
Clean version
1.15.2.1.2
N/A
Annotated version
1.15.2.1.3
N/A
Annotated labeling version
1.15.2.1.4
N/A
Annotated references
1.16
Risk management plans
Risk evaluation and mitigation strategies (REMS)
1.17
N/A
Postmarketing studies
1.17.1
N/A
Correspondence regarding postmarketing commitments
1.17.2
N/A
Correspondence regarding postmarketing requirements
1.18
N/A
Proprietary names
1.19
N/A
Pre-EUA and EUA
1.20
N/A
General investigational plan for initial IND
