[PRODUCT NAME, STRENGTH[ CONFIDENTIAL
Module 1 – Overall Table of Contents
Overall CTD Table of Contents
ModuleDescription Vol Page
Module 1Regional Administrative Information...... 1x
1.1Forms ...... 1x
1.1.1FDA Form 1571...... (not applicable)
1.1.2FDA Form 356h...... 1x
1.1.3User Fee Cover Sheet (FDA Form 3397)...... 1x
1.1.4Annual Report Transmittal Form (FDA Form 2252)...... (not applicable)
1.1.5Advertising and Promotional Labelling Form (FDA Form 2253)...... (not applicable)
1.1.6Transmittal of Labels and Circulars (FDA Form 2567)...... (not applicable)
1.2Cover Letter ...... 1x
- Comprehensive Table of Contents for Modules 1 - 5...... 1x
1.3Administrative Information ...... 1x
1.3.1Contact/Sponsor Information...... 1x
1.3.2Field Copy Certification...... 1x
1.3.3Debarment Certification...... 1x
1.3.4Certification: Financial Interests and Arrangements of Clinical Investigators (FDA Form 3454)...... 1x
1.3.5Patent & Exclusivity...... 1x
1.3.5.1Patent Information (FDA Form 3542a)...... 1x
1.3.5.2Patent Certification...... 1x
1.3.5.3Statement of Claimed Exclusivity...... 1x
1.4References...... 1x
1.4.1Letters of Authorization...... 1x
1.4.2Statement of Right of Reference...... (not applicable)
1.4.3List of Authorized Persons to Incorporate by Reference...... (not applicable)
1.4.4Cross Reference to Other Applications & Previously Submitted Information...... 1x
1.5Application Status ...... 1x
1.5.1IND Withdrawal Request...... 1x
1.5.2Inactivation Request...... 1x
1.5.3Reactivation Request...... 1x
1.5.4Reinstatement Request...... 1x
1.5.5Withdrawal of an Unapproved Application...... 1x
1.5.6Withdrawal of a Listed Drug...... 1x
1.5.7Request for Withdrawal of Application Approval...... 1x
1.5.8Other Correspondence...... 1x
Module 1Regional Administrative Information (continued)...... 1x
1.6Meetings...... 1x
1.6.1Meeting Request...... 1x
1.6.2Meeting Background Materials...... 1x
1.6.3Correspondence Regarding Meetings...... 1x
1.7Fast Track(not applicable)
1.8Special Protocol Assessment (SAP) Request...... (not applicable)
1.9Pediatric Administrative Information...... 1x
1.9.1Request for Waiver...... (not applicable)
1.9.2Request for Deferral...... (not applicable)
1.9.3Request for Pediatric Exclusivity Determination...... (not applicable)
1.9.4Proposed Pediatric Study Request & Amendments...... (not applicable)
1.9.5Proposal for Written Agreement...... (not applicable)
1.9.6Other Correspondence Regarding Pediatric Exclusivity or Study Plans...... 1x
1.10Dispute Resolutions...... (not applicable)
1.10.1Request for Dispute Resolution
1.10.2Correspondence Relating to Dispute Resolution
1.11Information Amendment (not covered under Modules 2 – 5)...... (not applicable)
1.11.1Quality
1.11.2Safety
1.11.3Efficacy
1.12Other Correspondence...... 1x.
1.12.1Pre-IND Correspondence...... 1x
1.12.2Request to Charge...... (not applicable)
1.12.3Notification of Charging Under Treatment IND...... (not applicable)
1.12.4Request for Comments and Advice on an IND...... 1x
1.12.5Request for Waiver...... (not applicable)
1.12.6Exemption from Informed Consent for Emergency Research...... (not applicable)
1.12.7Public Disclosure Statement for Emergency Care Research...... (not applicable)
1.12.8Correspondence Regarding Emergency Care Research...... (not applicable)
1.12.9Notification of Discontinuation of Clinical Trial...... (not applicable)
1.12.10Generic Drug Enforcement Act (GDEA) Statement...... 1x
1.12.11Basis for Submission Statement...... 1x
1.12.12Comparison of Generic Drug and Reference Listed Drug (RLD)...... 1x
1.12.13Request for Waiver of in vivo Studies...... 1x
1.12.14Environmental Impact Analysis Statement...... 1x
1.12.15Request for Waiver of in vivo Bioavailability Studies...... 1x
1.12.16Field Alert Reports...... (not applicable)
Module 1Regional Administrative Information (continued)...... 1x
1.13Annual Reports...... (not applicable)
1.13.1Summary for Non-Clinical Studies
1.13.2Summary of Clinical Pharmacology Studies
1.13.3Summary of Safety Information
1.13.4Summary of Labelling Changes
1.13.5Summary of Manufacturing Changes
1.13.6Summary of Microbiological Changes
1.13.7Summary of Other Significant New Information
1.13.8Individual Study Information
1.13.9General Investigational Plan
1.13.10Foreign Marketing History
1.13.11Distribution Data
1.13.12Status of Post-Marketing Commitments
1.13.13Status of Other Post-Marketing Studies
1.13.14Log of Outstanding Regulatory Business
1.14Labelling...... 1x
1.14.1Draft Labelling...... 1x
1.14.1.1Draft Carton & Container Labels...... 1x
1.14.1.2Annotated Draft Labelling Text...... 1x
1.14.1.3Draft Labelling Text...... 1x
1.14.1.4Label Comprehension Studies...... (not applicable)
1.14.1.5Labelling History...... 1x
1.14.2Final Labelling...... 1x
1.14.2.1Final Carton & Container Labels...... 1x
1.14.2.2Final Package Inserts...... 1x
1.14.2.3Final Labelling Text...... 1x
1.14.3Listed Drug Labelling...... 1x
1.14.3.1Annotated Comparison with Listed Drug...... 1x
1.14.3.2Approved Labelling Text for Listed Drug...... 1x
1.14.3.3Labelling Text for Reference Listed Drug...... 1x
1.14.4Investigational Drug Labelling...... 1x
1.14.4.1Investigator’s Brochure...... 1x
1.14.4.2Investigational Drug Labelling...... 1x
1.14.4.3FILL IN...... 1x
1.14.4.4FILL IN...... 1x
1.14.4.5Foreign Labelling...... (not applicable)
1.15Promotional Material...... 1x
1.16Risk Management Plans...... 1x
Module 2Common Technical Document Summaries...... xx
2.1Comprehensive Table of Contents for Module 2...... 1x
2.2Introduction...... 1x
2.3Quality Summary...... 1x
2.3.SDrug Substance...... 1x
2.3.S.1 General Information...... 1x
2.3.S.2Manufacture...... 1x
2.3.S.3Characterization...... 1x
2.3.S.4Control of Drug Substance...... 1x
2.3.S.5Reference Standards or Materials...... 1x
2.3.S.6Container/Closure System...... 1x
2.3.S.7Stability...... 1x
2.3.PDrug Product...... 1x
2.3.P.1 Description and Composition of the Drug Product...... 1x
2.3.P.2Pharmaceutical Development...... 1x
2.3.P.3Manufacture...... 1x
2.3.P.4Control of Excipients...... 1x
2.3.P.5Control of Drug Product...... 1x
2.3.P.6Reference Standards or Materials...... 1x
2.3.P.7Container/Closure System...... 1x
2.3.P.8Stability...... 1x
2.3.AAppendices...... 1x
2.3.A.1Facilities and Equipment...... 1x
2.3.A.2Adventitious Agents Safety Evaluation...... 1x
2.3.A.3Novel Excipients...... 1x
2.3.RRegional Information...... 1x
2.4Nonclinical Overview...... 1x
2.4.1Overview of the Nonclinical Testing Strategy...... 1x
2.4.2Pharmacology...... 1x
2.4.3Pharmacokinetics...... 1x
2.4.4Toxicology...... 1x
2.4.5Integrated Overview and Conclusions...... 1x
2.4.6List of Literature Citations...... 1x
2.5Clinical Overview...... 1x
2.5.1Product Development Rationale...... 1x
2.5.2Overview of Biopharmaceutics...... 1x
2.5.3Overview of Clinical Pharmacology...... 1x
2.5.4Overview of Efficacy...... 1x
2.5.5Overview of Safety...... 1x
2.5.6Benefits and Risks Conclusions...... 1x
2.5.7References...... 1x
Module 2Common Technical Document Summaries (continued)...... xx
2.6Nonclinical Written and Tabulated Summaries...... 1x
2.6.1Introduction...... 1x
2.6.2Pharmacology Written Summary...... 1x
2.6.2.1Brief Summary...... 1x
2.6.2.2Primary Pharmacodynamics...... 1x
2.6.2.3Secondary Pharmacodynamics...... 1x
2.6.2.4Safety Pharmacology...... 1x
2.6.2.5Pharmacodynamic Drug Interactions...... 1x
2.6.2.6Discussion and Conclusions...... 1x
2.6.2.7Tables and Figures...... 1x
2.6.3Pharmacology Tabulated Summary...... 1x
2.6.4Pharmacokinetics Written Summary...... 1x
2.6.4.1Brief Summary...... 1x
2.6.4.2Methods of Analysis...... 1x
2.6.4.3Absorption ...... 1x
2.6.4.4Distribution ...... 1x
2.6.4.5Metabolism (interspecies comparison)...... 1x
2.6.4.6Excretion ...... 1x
2.6.4.7Pharmacokinetic Drug Interactions...... 1x
2.6.4.8Other Pharmacokinetic Studies...... 1x
2.6.4.9Discussion and Conclusions...... 1x
2.6.4.10Tables and Figures...... 1x
2.6.5Pharmacokinetics Tabulated Summary...... 1x
2.6.6Toxicology Written Summary...... 1x
2.6.6.1Brief Summary...... 1x
2.6.6.2Single-Dose Toxicity...... 1x
2.6.6.3Repeat-Dose Toxicity...... 1x
2.6.6.4Genotoxicity ...... 1x
2.6.6.5Carcinogenicity...... 1x
2.6.6.6Reproductive and Developmental Toxicity...... 1x
2.6.6.7Local Tolerance...... 1x
2.6.6.8Other Toxicity Studies (if available)...... 1x
2.6.6.9Discussion and Conclusions...... 1x
2.6.6.10References ...... 1x
2.6.7Toxicology Tabulated Summary...... 1x
Module 2Common Technical Document Summaries (continued)...... xx
2.7Clinical Summary...... 1x
2.7.1Summary of Biopharmaceutic and Associated Analytical Methods...... 1x
2.7.1.1Background and Overview...... 1x
2.7.1.2Summary of Results of Individual Studies...... 1x
2.7.1.3Comparison and Analyses of Results Across Studies...... 1x
2.7.1.4Appendix ...... 1x
2.7.2Summary of Clinical Pharmacology Studies...... 1x
2.7.2.1Background and Overview...... 1x
2.7.2.2Summary of Results of Individual Studies...... 1x
2.7.2.3Comparison and Analyses of Results Across Studies...... 1x
2.7.2.4Special Studies ...... 1x
2.7.2.5Appendix ...... 1x
2.7.3Summary of Clinical Efficacy...... 1x
2.7.3.1Background and Overview of Clinical Efficacy...... 1x
2.7.3.2Summary of Results of Individual Studies...... 1x
2.7.3.3Comparison and Analyses of Results Across Studies...... 1x
2.7.3.3.1Study Populations ...... 1x
2.7.3.3.2Comparison of Efficacy Results Across All Studies...... 1x
2.7.3.3.3Comparison of Results in Sub-Populations...... 1x
2.7.3.4Analysis of Clinical Information Relevant to Dosing Recommendations...... 1x
2.7.3.5Persistence of Efficacy and/or Tolerance Effects...... 1x
2.7.3.6Appendix ...... 1x
2.7.4Summary of Clinical Safety...... 1x
2.7.4.1Exposure to the Drug...... 1x
2.7.4.1.1Overall Safety Evaluation Plan and Narratives of Safety Studies...... 1x
2.7.4.1.2Overall Extent of Exposure...... 1x
2.7.4.1.3Demographic and Other Characteristics of Study Population...... 1x
2.7.4.2Adverse Events ...... 1x
2.7.4.2.1Analysis of Adverse Eventsby Organ System or Syndrome...... 1x
2.7.4.2.2Narratives 1...... x
2.7.4.2.3Deaths 1...... x
2.7.4.2.4Other Serious Adverse Events...... 1x
2.7.4.3Clinical Laboratory Evaluations...... 1x
2.7.4.4Vital Signs, Physical Findings, Observations Related to Safety...... 1x
2.7.4.5Safety in Special Groups and Situations...... 1x
2.7.4.5.1Intrinsic Factors ...... 1x
2.7.4.5.2Extrinsic Factors ...... 1x
2.7.4.5.3Drug Interactions ...... 1x
2.7.4.5.4Use in Pregnancy and Lactation...... 1x
2.7.4.5.5Overdose 1...... x
2.7.4.5.6Drug Abuse ...... 1x
2.7.4.5.7Withdrawal and Rebound...... 1x
2.7.4.5.8Effects on Ability to Drive or Operate Machinery or Impairment of Mental Ability...... 1x
2.7.4.6Post-Marketing Data...... 1x
2.7.4.7Appendix ...... 1x
2.7.5References...... 1x
2.7.6Synopses of Individual Studies...... 1x
Module 3Quality...... 2x
3.1Comprehensive Table of Contents for Module 3...... 2x
3.2Drug Substance...... 2x
3.2.S.1General Information...... 2x
3.2.S.1.1Nomenclature...... 2 x
3.2.S.1.2Structure...... 2 x
3.2.S.1.3General Properties...... 2x
3.2.S.2Manufacture...... 2x
3.2.S.2.1Manufacturer(s)...... 2 x
3.2.S.2.2Description of Process and Process Controls...... 2x
3.2.S.2.3Control of Materials...... 2x
3.2.S.2.4Control of Critical Steps and Intermediates...... 2x
3.2.S.2.5Process Validation and/or Evaluation...... 2x
3.2.S.3Characterization...... 2x
3.2.S.3.1Elucidation of Structure and Other Characteristics...... 2x
3.2.S.3.2Impurities...... 2 x
3.2.S.4Control of Drug Substance...... 2x
3.2.S.4.1Specifications...... 2 x
3.2.S.4.2Analytical Procedures...... 2x
3.2.S.4.3Validation of Analytical Procedures...... 2x
3.2.S.4.4Batch Analyses...... 2 x
3.2.S.4.5Justification of Specification...... 2x
3.2.S.5Reference Standards or Materials...... 2x
3.2.S.6Container/Closure Systems...... 2x
3.2.S.7Stability...... 2x
3.2.S.7.1Stability Summary and Conclusions...... 2x
3.2.S.7.2Post-approval Stability Protocol and Commitment...... 2x
3.2.S.7.3Stability Data...... 2 x
3.2.PDrug Product...... 3 x
3.2.P.1 Description and Composition of the Drug Product...... 3x
3.2.P.2Pharmaceutical Development...... 3x
3.2.P.2.1Composition of Drug Product...... 3x
3.2.P.2.2Formulation, Overages, Properties...... 3x
3.2.P.2.3Manufacturing Process Development...... 3x
3.2.P.2.4Container/Closure System...... 3x
3.2.P.2.5Microbiological Attributes...... 3x
3.2.P.2.6Compatibility...... 3 x
3.2.P.3Manufacture...... 3x
3.2.P.3.1Manufacturer(s)...... 3x
3.2.P.3.2Batch Formula...... 3x
3.2.P.3.3Description of Manufacturing Process and Process Controls...... 3x
3.2.P.3.4Controls of Critical Steps and Intermediates...... 3x
3.2.P.3.5Process Validation and/or Evaluation...... 3x
3.2.P.4Control of Excipients...... 3x
3.2.P.4.1Specifications...... 3 x
3.2.P.4.2Analytical Procedures...... 3x
3.2.P.4.3Validation of Analytical Procedures...... 3x
3.2.P.4.4Justification of Specifications...... 3x
3.2.P.4.5Excipients of Human or Animal Origin...... 3x
3.2.P.4.6Novel Excipients...... 3x
3.2.P.5Control of Drug Product...... 3x
3.2.P.5.1Specifications...... 3 x
3.2.P.5.2Analytical Procedures...... 3x
3.2.P.5.3Validation of Analytical Procedures...... 3x
3.2.P.5.4Batch Analyses...... 3x
3.2.P.5.5Characterization of Impurities...... 3x
3.2.P.5.6Justification of Specifications...... 3x
3.2.P.6Reference Standards or Materials...... 3x
3.2.P.7Container/Closure System...... 3x
3.2.P.8Stability...... 3x
3.2.P.8.1Stability Summary and Conclusions...... 3x
3.2.P.8.2Post-Approval Stability Protocol and Stability Commitments...... 3x
3.2.P.8.3Stability Data...... 3 x
3.2.AAppendices...... 4 x
3.2.A.1Facilities and Equipment...... 4x
3.2.A.2Adventitious Agents Safety Evaluation...... 4x
3.2.A.3Novel Excipients...... 4x
3.2.RRegional Information...... 4 x
3.2.R.1Batch Records
Lot #### (STRENGTH)...... 4x
Lot#### (STRENGTH)...... 5x
3.2.R.2Methods Validation Packet...... 5x
3.3Key Literature References...... 5x
Module 4Non-Clinical Study Reports...... 6x
4.1Comprehensive Table of Contents for Module 4...... 6x
4.2Study Reports...... 6x
4.2.1Pharmacology...... 6x
4.2.1.1Primary Pharmacodynamics...... 6x
4.2.1.2Secondary Pharmacodynamics...... 6x
4.2.1.3Safety Pharmacology...... 6x
4.2.1.4Pharmacodynamic Drug Interactions...... 6x
4.2.2Pharmacokinetics...... 6x
4.2.2.1Analytical Methods and Validation Reports...... 6x
4.2.2.2Absorption ...... 6x
4.2.2.3Distribution ...... 6x
4.2.2.4Metabolism ...... 6x
4.2.2.5Excretion ...... 6x
4.2.2.6Pharmacokinetic Drug Interactions...... 6x
4.2.2.7Other Pharmacokinetic Studies...... 6x
4.2.3Toxicology...... 6x
4.2.3.1Single-Dose Toxicity...... 6x
4.2.3.2Repeat-Dose Toxicity...... 6x
4.2.3.3Genotoxicity ...... 6x
4.2.3.3.1In vitro Studies ...... 6x
4.2.3.3.2In vivo Studies ...... 6x
4.2.3.4Carcinogenicity...... 6x
4.2.3.5Reproductive and Development Toxicity...... 6x
4.2.3.5.1Fertility and Embryonic Development...... 6x
4.2.3.5.2Embryo-Fetal Development...... 6x
4.2.3.5.3Pre- and Post-natal Development & Maternal Function...... 6x
4.2.3.5.4Offspring, Juvenile, Second & Third-Generation Studies...... 6x
4.2.3.6Local Tolerance...... 6x
4.2.3.7Other Toxicity Studies...... 6x
4.2.3.7.1Antigenicity ...... 6x
4.2.3.7.2Immunogenicity ...... 6x
4.2.3.7.3Mechanistic Studies (not included elsewhere)...... 6x
4.2.3.7.4Dependence ...... 6x
4.2.3.7.5Metabolites ...... 6x
4.2.3.7.6Impurities 6...... x
4.2.3.7.7Other 6...... x
4.3Literature References...... 6x
Module 5Clinical Study Reports...... 7x
5.1Comprehensive Table of Contents for Module 5...... 7x
5.2Tabular Listing of All Clinical Studies...... 7x
5.2.1CLIENT Studies...... 7x
5.2.2Tabular Listing of Clinical Investigators...... 7x
5.3Clinical Study Reports...... 7x
5.3.1Reports of Biopharmaceutic Studies...... 7x
5.3.1.1Bioavailability (BA) Study Reports...... 7x
5.3.1.1.1CLIENT Studies...... 7x
- Protocol #### (Food-Effect)...... 7x
- Protocol #### (Food-Effect) (continued)...... 8x
- Protocol #### (Food-Effect) (continued)...... 9x
- Protocol #### (Food-Effect) (continued)...... 10x
- REFERENCE LISTED DRUG SPONSOR STUDIES...... 10x
- Fill in data from NDA Summary Basis of Approval Review...... 10x
- Published Studies...... 10x
- Summary...... 10x
- Comparative BA & BE Study Reports...... 11x
- CLIENTStudies...... 111
- Protocol #### ...... 118
- Appendices 16.0...... 1140
- Appendices 16.1 – Study Information...... 1140
- Appendices 16.1.1 – Protocol & IRB Approval...... 1140
- Appendices 16.1.2 – Sample Case Report Form (CRF)...... 1158
- Appendices 16.1.3 – IRB Membership Roster...... 1169
- Appendices 16.1.4 – List of Investigators...... 1178
- Appendices 16.1.5 – Signature Page...... 11113
- Appendices 16.1.6 – Table of Dosing Dates and Times...... 11114
- Appendices 16.1.7 – Randomization Scheme and Codes...... 11123
- Appendices 16.1.8 – Audit Certificate...... 11124
- Appendices 16.1.9 – Statistical Report...... 11125
- Protocol #### (continued)...... 12
- Appendices 16.1.9 – Statistical Report (continued)...... 121
- Appendices 16.1.10 – Analytical Report...... 12132
- Addendum to Method Validation Report...... 12200
- Protocol #### (continued)...... 13
- Appendices 16.1.10 – Analytical Report (continued)...... 131
- Appendix 16.1.11 – Publications Based on this Study (NA)...... 13-
- Appendix 16.1.12 – Publications Referenced in Report (NA)...... 13-
- Appendix 16.2 – Subject Data Listings...... 13419
- Appendix 16.2.1 – Discontinued Subjects...... 13419
- Appendix 16.2.2 – Protocol Deviations (none)...... 13-
- Appendix 16.2.3 – Concomitant Medications...... 13421
- Appendix 16.2.4 – Subject Demographics...... 13422
- Appendix 16.2.5 – Table of Deviations from Scheduled Collections...... 13425
- Appendix 16.2.6 – Individual Efficacy Response (NA)...... 13-
- Appendix 16.2.7 – Adverse Event Listings...... 13426
- Appendix 16.2.8 – Listing of Individual Lab Measurements ((NA)...... 13-
- Appendix 16.3 – Case Report Forms (CRF) (Subjects 1 – 44)...... 13-
- Appendix 16.3.1 – CRFs for Deaths, Serious AE, & Discontinuations...... 17XX
- Appendix 16.3.2 – Other CRFs Submitted (NA)...... 13-
- Appendix 16.4 – Individual Patient Listings...... 17XX
- Protocol #### ...... 14
- Protocol #### ...... 141
- Appendices 16.0...... 1480
- Appendices 16.1 – Study Information...... 1480
- Appendices 16.1.1 – Protocol & Protocol Amendments...... 1481
- Appendices 16.1.2 – Sample Case Report Form (CRF)...... 14187
- Appendices 16.1.3 – IRB Membership & Sample Informed Consent...... 14219
- Appendices 16.1.4 – List of Investigators...... 14270
- Appendices 16.1.5 – Signature Page...... 14278
- Appendices 16.1.6 – List of Subjects Receiving Test Drugs from
Multiple Batches (NA)...... 14-
- Appendices 16.1.7 – Randomization Scheme and Codes...... 14281
- Appendices 16.1.8 – Audit Certificate (NA)...... 14-
- Appendices 16.1.9 – Documentation of Pharmacokinetic and
Statistical Methods...... 14285
- Appendices 16.1.10 – Documentation of Inter-Laboratory
Standardization Methods and QA Procedures...... 14304
- Appendix 16.1.11 – Publications Based on this Study (NA)...... 14320
- Appendix 16.1.12 – Publications Referenced in Report (NA)...... 14321
- Protocol #### (continued)...... 15
- Appendix 16.2 – Subject Data Listings...... 152
- Appendix 16.2.1 – Discontinued Subjects (none)...... 153
- Appendix 16.2.2 – Protocol Deviations – Blood Samples...... 155
- Appendix 16.2.3 – Subjects Excluded from Analysis (none)...... 157
- Appendix 16.2.4 – Demographic Data & Baseline Characteristics...... 159
- Appendix 16.2.5 – Drug Concentration Data...... 1512
- Appendix 16.2.6 – Individual Data...... 1548
- Appendix 16.2.7 – Adverse Event Listings...... 1593
- Appendix 16.2.8 – Listing of Individual Lab Measurements...... 15103
- Appendix 16.2.9 – Statistical Analysis...... 15177
- Appendix 16.3 – Case Report Forms (CRF)...... 15196
- Appendix 16.3.1 – CRFs for Deaths, Other Serious Adverse Events, &
Withdrawals for AE (none)...... 15196
- Appendix 16.3.2 – Other CRFs Submitted (NA)...... 15198
- Appendix 16.4 – Individual Subject Data Listings...... 15199
- Appendix 16.5 – Analytical Report...... 15200
- Appendix 16.6 – Validation Report...... 15365
- REFERENCE LISTED DRUG SPONSOR STUDIES...... 16x
- FILL IN AS NEEDED: Summary Basis of Approval Review...... 16x
- FILL IN AS NEEDED: Summary Basis of Approval Review...... 16x
- FILL IN AS NEEDED: Summary Basis of Approval Review...... 16x
- Published Studies...... 16x
- Summary...... 16x
- In vitro/In vivo Correlation (IV/IVC)...... 16x
- Bioanalytical and Analytical Methods...... 16x
- Reports of Studies Pertinent to Human PK...... 16x
- Plasma Protein Binding Study Reports...... 16x
- Hepatic Metabolism/Drug Interactions...... 16x
- Studies Using other Human Materials...... 16x
- Reports of Human PK Studies...... 16x
- Healthy Subject PK and Tolerability...... 16x
- Patient PK and Initial Tolerability...... 16x
- Intrinsic Factor PK...... 16x
- Extrinsic Factor PK...... 16x
- Population PK...... 16x
- Reports of Human PD Studies...... 16x
- Healthy Subject PD and PK/PD Studies...... 16x
- Patient PD and PK/PD...... 16x
- Reports of Efficacy and Safety Studies...... 16x
- Controlled Clinical Studies on Indication...... 16x
5.3.5.1.AINDICATION # 1...... 16x
5.3.5.1.A.1 CLIENT Studies...... 16x
5.3.5.1.A.2 NDA ##,### Sponsor Studies...... 16x
5.3.5.1.A.3 Published Studies...... 16x
5.3.5.1.A.4 Summary...... 16x
5.3.5.3.1.BINDICATION # 2...... 16x
5.3.5.1.B.1 CLIENTStudies...... 16x
5.3.5.1.B.2 NDA ##,### Sponsor Studies...... 16x
5.3.5.1.B.3 Published Studies...... 16x
5.3.5.1.B.4 Summary...... 16x
5.3.5.2Uncontrolled Clinical Studies...... 16x
5.3.5.2.1CLIENTStudies...... 16x
5.3.5.2.2NDA ##,### Sponsor Studies...... 16x
- Summary Basis of Approval: Clinical Review...... 16x
- Published Studies...... 16x
- Summary...... 16x
- Reports of Analyses of Data from More than One Study...... 16x
- Integrated Summary of Safety...... 16x
5.3.5.3.1.AINDICATION # 1...... 16x
5.3.5.3.1.BINDICATION # 2...... 16x
5.3.5.3.2Integrated Summary of Efficacy...... 16x
- INDICATION # 1...... 16x
- INDICATION # 2...... 16x
- Other Clinical Study Reports...... 17x
- Reports of Post-Marketing Experience...... 17x
- Regulatory History of NDA ##,###...... 17x
- Generic Approvals...... 17x
- Safety Data from Post-Marketing Surveillance...... 17x
- Foreign Marketing Data in Support of the Original NDA...... 17x
- US Post-Marketing Surveillance Data...... 17x
- Case Report Forms (CRF)/Individual Patient Listings...... 17x
- Protocol ##### – BE Study...... 17x
- Protocol ##### – Food-Effect Study...... 17x
- Literature References...... 18x
Literature References (continued)...... 19x
1