Module 1 CA

• 1.0.1 CA Cover Letter
• 1.0.4 CA Health Canada Solicited Information
• 1.0.7 CA General Note to Reviewer
• 1.2.4.2 CA Data Protection Information
• 1.3.1 CA Product Monograph
• 1.3.4 CA Investigator Brochure
• 1.3.7 CA Look-alike Sound-alike Assessment
• 1.3.8.2 CA Risk Management Plan
• 1.4.1 CA PSEAT-CTA
• 1.5 CA Environmental Assessment Statement
• 1.7.4 CA Information on Prior-related Applications
• CA Clinical Study Protocol Phase I
• CA Clinical Study Protocol Phase II-III

Module 1 EU

• 1.0 EU Cover Letter
• 1.3.4 EU Consultation with Target Patient Groups
• 1.4.1 EU Information About the Experts Quality
• 1.4.2 EU Information About the Experts NonClinical
• 1.4.3 EU Information About the Experts Clinical
• 1.5.1 EU Information for Bibliographical Applications
• 1.5.2 EU Information for Generic Hybrid Bio-similar Applic
• 1.5.3 EU Extended Data Market Exclusivity
• 1.5.4 EU Exceptional Circumstance
• 1.5.5 EU Conditional Marketing Authorisation
• 1.6.1 EU Environmental Risk Assessment Non-GMO
• 1.7.1 EU Information Relating to Orphan Market Exclusivity
• 1.7.2 EU Information Relating to Orphan Market Exclusivity
• 1.8.1 EU Pharmacovigilance System
• 1.8.2 EU Risk Management Plan
• 1.9 EU Information Relating to Clinical Trials
• Core Data Sheet
• EU Response to List of Questions
• IMPD base template

Module 1 US

• 1.10.1 Request for Dispute Resolution
• 1.10.2 Correspondence Related to Dispute Resolution
• 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
• 1.12.1 Pre-IND Correspondence
• 1.12.13 Request for Waiver for In Vivo Studies
• 1.12.14 Environmental Assessment - Categorical Exclusion
• 1.12.14 Environmental Assessment
• 1.12.15 Request for Waiver for In Vivo Bioavailability Stu
• 1.12.16 Field Alert Reports
• 1.12.17 Orphan Drug Designation
• 1.12.2 Request to Charge for Clinical Trial
• 1.12.3 Request to Charge for Expanded Access
• 1.12.4 Request for Comment_Advice
• 1.12.5 Request for a Waiver
• 1.12.6 Exemption from Informed Consent for Emergency Resea
• 1.12.7 Public Disclosure Statement for Exemption from Info
• 1.12.8 Correspondence Regarding Exemption from Informed Co
• 1.12.9 Notification of Discontinuation of Clinical Trial
• 1.13.1 Summary for Nonclinical Studies - IND Annual Report
• 1.13.1 Summary for Nonclinical Studies - NDA Annual Report
• 1.13.10 Foreign Marketing
• 1.13.11 Distribution Data
• 1.13.12 Status of Postmarketing Study Commitments and Requ
• 1.13.13 Status of Other Postmarketing Studies and Requirem
• 1.13.14 Log of Outstanding Regulatory Business - IND Annua
• 1.13.14 Log of Outstanding Regulatory Business - NDA Annua
• 1.13.15 Development Safety Update Report (DSUR)
• 1.13.2 Summary for Clinical Pharmacology Information - IND
• 1.13.2 Summary for Clinical Pharmacology Information - NDA
• 1.13.3 Summary of Safety Information - IND Annual Report
• 1.13.3 Summary of Safety Information - NDA Annual Report
• 1.13.4 Summary of Labeling Changes
• 1.13.5 Summary of Manufacturing Changes - IND Annual Repor
• 1.13.5 Summary of Manufacturing Changes - NDA Annual Repor
• 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
• 1.14 Labeling - NDA Annual Report_Placeholder
• 1.14.1.2 Annotated Draft Labeling Text
• 1.14.1.4 Labeling Comprehension Studies
• 1.14.1.5 Labeling History
• 1.14.2.1 Final Carton and Container Labels
• 1.14.2.2 Final Package Insert_Placeholder
• 1.14.2.3 Final Labeling Text_Placeholder
• 1.14.3.1 Annotated Comparison with Reference Listed Drug (
• 1.14.3.2 Approved Labeling Text for Reference Listed Drug
• 1.14.3.3 Labeling Text for Reference Listed Drug (RLD)
• 1.14.4.1 Annual Report Investigational Brochure_Placeholde
• 1.14.4.1 Investigator's Brochure
• 1.14.4.2 Investigational Drug Labeling
• 1.14.5 Foreign Labeling
• 1.14.6 Product Labeling for 2253 Submissions
• 1.15 General Considerations
• 1.15 Presentation Issues
• 1.15 Promotional Complaints
• 1.15 Promotional Format for Electronic Submission
• 1.15 Promotional Material Submitted in Fulfillment of the
• 1.15 Promotional Materials Paper Hard Copy
• 1.15.1.1 Request for Advisory Comments on Launch Materials
• 1.15.1.10 Submission of Annotated References
• 1.15.1.11 General Correspondence
• 1.15.1.3 Presubmission of Launch Promotional Meterials for
• 1.15.1.4 Presubmission of Non-Launch Promotional Materials
• 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
• 1.15.1.9 Withdrawal Request
• 1.16 Proposed Risk Evaluation and Mitigation Strategies (R
• 1.16 Proposed Risk Evaluation and Mitigation Strategies (R
• 1.16 Proposed Risk Evaluation and Mitigation Strategies (R
• 1.16 Risk Management Plans
• 1.16.2.1 Final REMS_Placeholder
• 1.16.2.2 Draft REMS_Placeholder
• 1.16.2.3 Risk Evaluation and Mitigation Strategies (REMS)
• 1.16.2.4 Risk Evaluation and Mitigation Strategies (REMS)
• 1.16.2.5 Risk Evlauation and Mitigation Strategies (REMS)
• 1.16.2.6 Risk Evlauation and Mitigation Strategies (REMS)
• 1.17.1 Correspondence Regarding Postmarketing Commitments
• 1.17.2 Correspondence Regarding Postmarketing Requirements
• 1.19 Emergency Use Authorization Request
• 1.2 Cover Letter - Initial IND Application
• 1.2 Cover Letter - Original NDA Application
• 1.2 Reviewer Guide
• 1.20 General Investigational Plan for Initial IND-2
• 1.20 General Investigational Plan for Initial IND
• 1.3.1.1 Change of Address
• 1.3.1.2 Change of Contact Agent
• 1.3.1.3 Change of Sponsor
• 1.3.1.4 Transfer of Obligation
• 1.3.1.5 Change in Ownership of an Application or Reissuanc
• 1.3.2 Field Copy Certification
• 1.3.3 Debarment Certification
• 1.3.4 Financial Certification and Disclosure
• 1.3.5.1 Patent Information_Placeholder
• 1.3.5.2 Patent Certifications
• 1.3.5.3 Exclusivity Claim
• 1.3.6 Tropical Disease Piority Review Voucher
• 1.4.1 Letter of Authorization_Placeholder
• 1.4.2 Statement of Right of Reference_Placeholder
• 1.4.4 Cross-reference to Previously Submitted Information
• 1.5.1 Withdrawal of IND
• 1.5.2 Inactivation Request
• 1.5.3 Reactivation Request
• 1.5.4 Reinstatement Request
• 1.5.5 Withdrawal of an Unapproved Application
• 1.5.6 Withdrawal of a Listed Drug
• 1.5.7 Request for Withdrawal of Application Approval or Re
• 1.6.1 Meeting Request
• 1.6.1 Meeting Request_Biosimilar_Biologics
• 1.6.2 Pre-IND Meeting Background Materials
• 1.6.2 Pre-NDA Meeting Background Materials
• 1.6.3 Correspondence Regarding Meetings-1
• 1.7.1 Fast Track Designation
• 1.7.2 Fast Track Designation Withdrawal Request
• 1.7.3 Rolling Review Request
• 1.8.1 Special Protocol Assessment Request_Clinical Study
• 1.8.2 Special Protocol Assessment_Carcinogenicity Study
• 1.8.2 Special Protocol Assessment_Carcinogenicity_Intent N
• 1.8.3 Special Protocol Assessment Request_Stability Study
• 1.9.1 Request for Waiver of Pediatric Studies
• 1.9.2 Request for Deferral of Pediatric Studies
• 1.9.4 Pediatric Study Plan
• 1.9.6 Other Correspondence Regarding Pediatric Exclusivity
• Breakthrough Therapy Designation
• Clinical Data - NDA Annual Report_Placeholder
• CMC - NDA Annual Report_Placeholder
• Core Data Sheet - 1
• IB Update Summary of Changes
• Nonclinical Studies - NDA Annual Report_Placeholder
• Paper IND to eCTD Conversion_Cover Letter
• Phase I Protocol Modifications - IND Annual Report_Placeho
• Physician's Labeling Rule_Content
• Request for Proprietary Name Review
• Target Product Profile

Module 2 Summaries

• 2.2 Introduction to Summary - IND
• 2.2 Introduction to Summary
• 2.3 Introduction to the Quality Overall Summary
• 2.3.A.1 Facilities and Equipment
• 2.3.A.2 Adventitious Agents Safety Evaluation
• 2.3.A.3 Novel Excipients
• 2.3.P Drug Product Non-granular
• 2.3.P.1 Description and Composition of the Drug Product
• 2.3.P.2 Pharaceutical Development
• 2.3.P.3 Manufacture
• 2.3.P.4 Control of Excipients
• 2.3.P.5 Control of Drug Product
• 2.3.P.6 Reference Standards or Materials
• 2.3.P.7 Container Closure System
• 2.3.P.8 Stability
• 2.3.R Regional Information
• 2.3.S Drug Substance Non-granular
• 2.3.S.1 General Information
• 2.3.S.2 Manufacture
• 2.3.S.3 Characterization
• 2.3.S.4 Control of Drug Substance
• 2.3.S.5 Reference Standards or Materials
• 2.3.S.6 Container Closure System
• 2.3.S.7 Stability
• 2.3A Appendices Non-granular
• 2.4 Nonclinical Overview
• 2.5 Clinical Overview
• 2.6.1 Introduction
• 2.6.2 Pharmacology Written Summary
• 2.6.3 Pharmacology Tabulated Summary
• 2.6.4 Pharmacokinetics Written Summary
• 2.6.5 Pharmacokinetics Tabulated Summary
• 2.6.6 Toxicology Written Summary
• 2.6.7 Toxicology Tabulated Summary
• 2.7.1 Summary of Biopharmaceutic Studies and Associated An
• 2.7.2 Summary of Clinical Pharmacology Studies
• 2.7.3 Summary of Clinical Efficacy
• 2.7.4 Summary of Clinical Safety
• 2.7.5 References
• 2.7.6 Synopses of Individial Studies

Module 3 Quality

• Granular Module 3 Templates
• 3.2.A.1 Facilities and Equipment
• 3.2.A.2 Adventitious Agents Safety Evaluation
• 3.2.A.3 Excipients
• 3.2.P.1 Description and Composition of the Drug Product No
• 3.2.P.2 Pharmaceutical Development Non-granular
• 3.2.P.2.1 Components of the Drug Product non-granular
• 3.2.P.2.2 Drug Product Non-granular
• 3.2.P.2.3 Manufacturing Process Development
• 3.2.P.2.4 Container Closure System
• 3.2.P.2.5 Microbiological Attributes
• 3.2.P.2.6 Compatibility
• 3.2.P.3.1 Manufacturers
• 3.2.P.3.2 Batch Formula
• 3.2.P.3.3 Description of Manufacturing Process and Process
• 3.2.P.3.4 Controls of Critical Steps and Intermediates
• 3.2.P.3.5 Process Validation and-or Evaluation
• 3.2.P.4.1 Specifications Non-granular
• 3.2.P.4.2 Analytical Procedures-Test Method
• 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.5.1 Specifications
• 3.2.P.5.2 Analytical Procedures-Test Method
• 3.2.P.5.2 Analytical Procedures
• 3.2.P.5.3 Validation of Analytical Procedures-Test Method
• 3.2.P.5.3 Validation of Analytical Procedures
• 3.2.P.5.4 Batch Analyses Non-granular
• 3.2.P.5.5 Characterization of Impurities
• 3.2.P.5.6 Justification of Specifications
• 3.2.P.6 Reference Standards or Materials
• 3.2.P.7.1 Container Closure System Non-granular
• 3.2.P.7.2 Container Closure System-Secondary Packaging
• 3.2.P.8.1 Stability Summary and Conclusion Non-granular
• 3.2.P.8.2 Postapproval Stability Protocol and Stability Co
• 3.2.P.8.3 Stability Data Non-granular
• 3.2.R Regional Information_Placeholder
• 3.2.R.2 Methods Validation Package
• 3.2.S.1.1 Nomenclature
• 3.2.S.1.2 Structure
• 3.2.S.1.3 General Properties
• 3.2.S.2.1 Manufacturers
• 3.2.S.2.2 Description of Manufacturing Process and Process
• 3.2.S.2.3 Control of Materials Non-granular
• 3.2.S.2.4 Control of Critical Steps and Intermediates Non-
• 3.2.S.2.5 Process Validation and-or Evaluation
• 3.2.S.2.6 Manufacturing Process Development
• 3.2.S.3.1 Elucidation of Structure and Other Characteristi
• 3.2.S.3.2 Impurities Non-granular
• 3.2.S.4.1 Specification
• 3.2.S.4.2 Analytical Procedures-Test Method
• 3.2.S.4.2 Analytical Procedures
• 3.2.S.4.3 Validation of Analytical Procedures-Test Method
• 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 System
• 3.2.S.7.1 Stability Summary and Conclusions Non-granular
• 3.2.S.7.2 Post-approval Stability Protocol and Stability C
• 3.2.S.7.3 Stability Data Non-granular
• 3.3 Literature References_Placeholder

Module 4 Safety

• 4.3 Literature References_Placeholder
• In Vitro Pharmacology Study Report
• In Vivo Pharmacology Study Report
• Pharmacokinetic Study Report
• Toxicology Protocol
• Toxicology Study Report

Module 5 Efficacy

• 16.1.1 Protocol and Amendments
• 16.1.10 Inter-Laboratory Standardization Methods and Quali
• 16.1.11 Publications Based on the Study
• 16.1.12 Publications Referenced in the Study
• 16.1.2 Sample CRF
• 16.1.3 IEC and IRB and Consent Form Listings
• 16.1.4 Description of Investigators and Sites
• 16.1.5 Investigator Signatures
• 16.1.6 Listing of Patients from Specified Batches
• 16.1.7 Randomization Scheme
• 16.1.8 Audit Certificate
• 16.1.9 Statistical Methods and Interim Analysis Plans
• 16.2.1 Discontinued Patients
• 16.2.2 Protocol Deviations
• 16.2.3 Patients Excluded from Efficacy Analysis
• 16.2.4 Demographic Data
• 16.2.5 Compliance and Drug Concentration Data
• 16.2.6 Individual Efficacy Response Data Phase II-III
• 16.2.6 Individual Pharmacokinetics Response Data Phase I
• 16.2.7 Adverse Event Listings
• 16.2.8 Individual Laboratory Measurements
• 16.3.1 CRFs for Deaths, SAEs, and Withdrawals
• 16.3.2 Other CRFs
• 5.2 Tabular Listing of All Clinical Studies
• 5.3.6 Reports of Post-Marketing Experience
• 5.4 Literature References_Placeholder
• Abbrev-16.1.1 Protocol and Amendments
• Abbrev-16.1.2 Sample CRF
• Abbrev-16.2.7 Adverse Event Listings
• Abbrev-16.3.1 CRFs for Deaths, SAEs, and Withdrawals
• Abbrev-Clinical Study Report_granular body
• Abbrev-Synopsis
• Amendment Summary of Changes_Complex Option
• Amendment Summary of Changes_Simple Option
• Clinical Study Protocol Phase I
• Clinical Study Protocol Phase II-III
• Clinical Study Report_granular body Phase I
• Clinical Study Report_granular body Phase II-III
• General Protocol Template
• Integrated Summary of Efficacy
• Integrated Summary of Safety
• PBRER
• Periodic Safety Update Report
• SAP ISE
• SAP ISS
• SAP Phase I
• SAP Phase II-III

ANDA

• 1.12.11 Basis for Submission_ANDA
• 1.12.12 Comparison Between Generic Drug and Reference
• 1.12.14 Environmental Assessment_ANDA
• 1.12.15 Request for Waiver of In Vivo Bioavailability
• 1.14.1.2 Annotated Draft Labeling Text_ANDA
• 1.14.3.1 Annotated Comparison with Listed Drug_ANDA
• 1.3.3 Debarment Certification_ANDA
• 1.3.5.2 Patent Certification_ANDA
• 2.3 Introduction to Quality Overall Summary_ANDA
• 2.3 Quality Overall Summary_ANDA
• 2.3.P.1 Description and Composition of the Drug Produ
• 2.3.P.2 Pharmaceutical Development_ANDA
• 2.3.P.3 Manufacture_ANDA
• 2.3.P.4 Control of Excipients_ANDA
• 2.3.P.5 Control of Drug Product_ANDA
• 2.3.P.6 Reference Standards or Materials_ANDA
• 2.3.P.7 Container Closure System_ANDA
• 2.3.P.8 Stability_ANDA
• 2.3.S.1 General Information_ANDA
• 2.3.S.2 Manufacture_ANDA
• 2.3.S.3 Characterization_ANDA
• 2.3.S.4 Control of Drug Substance_ANDA
• 2.3.S.5 Reference Standards or Materials_ANDA
• 2.3.S.6 Container Closure System_ANDA
• 2.3.S.7 Stability_ANDA
• 2.7.1 Summary of Biopharmaceutic Studies and Associat
• Bioequivalence Summary Data Tables_ANDA