# Presentation: 873860

## eCTD: Module 1Bronwyn Collier, Associate Director for Regulatory AffairsOffice of Drug Evalaution IIICenter for Drug Evaluation and ResearchFDA 

*April 2005*

## Module 1: Topics

- Purpose
- Impact on review process
- Module 1 table of contents

## Module 1: Purpose

- Archive regional documents
- Application management
- Status
- Business
- Special regulatory programs
- Provides the legal and regulatory framework for the application/submission

## Impact on Review Process

- Facilitates document processing
- Identification
- Division assignment
- Review assignment
- Guides response
- Satisfies some regulatory requirements

## TOC Mapping

| CFR Citation |  | eCTD/STF Heading |  |  |
| --- | --- | --- | --- | --- |
| NUMBER | TITLE | MODULE | NUMBER | TITLE |
| 312.7(d) | Charging for and commercialization of investigational drugs | 1 | 1.12.2 | Request to Charge |
| 312.10 | Waivers | 1 | 1.12.5 | Request for a waiver |
| 312.23 (a)(1) | Cover sheet (Form FDA 1571) | 1 | 1.1.1 | Application form: FDA form 1571 |
| 312.23(a)(2) | Table of Contents | N/A | N/A | N/A |
| 314.50(h) | Patent Information | 1 | 1.3.5.1 | Patent Information |

## Module 1 TOC

- 1.1 Forms
- 1.1.1 Application form: FDA form 1571
- 1.1.2 Application form: FDA form 356(h)
- 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 & circulars: FDA form 2567

## Module 1 TOC

- 1.2 Cover letters
- Submission identification
- Submission description
- Approximate submission size
- “Virus free” statement
- Regulatory & technical point of contact

## Module 1 TOC

- 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
- 1.3.2 Field copy certification
- 1.3.3 Debarment certification
- 1.3.4 Financial certification and disclosure

## Module 1 TOC

- 1.3.5 Patent and exclusivity
- 1.3.5.1 Patent information
**FDA form 3542a**
**FDA form 3542**
- 1.3.5.2 Patent Certifications
- 1.3.5.3 Exclusivity request
- 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 other applications and previously submitted information

## Module 1 TOC

- 1.5 Application status
- 1.5.1 IND Withdrawal request
- 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 listed drug
- 1.5.7 Request for withdrawal of application approval
- 1.5.8 Other correspondence re withdrawal or suspension of approval

## Module 1 TOC

- 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
- Correspondence re Fast Track/Rolling Review
- Correspondence re CMA Pilot 1
- Correspondence re CMA Pilot 2

## Module 1 TOC

- 1.8 Special protocol assessment request
- 1.8.1 Clinical study
- 1.8.2 Carcinogenicity study
- 1.8.3 Stability study

## Module 1 TOC

- 1.9 pediatric administrative information
- 1.9.1 Request for deferral
- 1.9.2 Request for waiver
- 1.9.3 Request for pediatric exclusivity determination
- 1.9.4 Proposed pediatric study request and amendments
- 1.9.5 Proposal for written agreement
- 1.9.6 Other correspondence regarding pediatric exclusivity or study plans

## Module 1 TOC

- 1.10 Dispute resolution
- 1.10.1 Request for dispute resolution
- 1.10.2 Correspondence related to dispute resolution
- 1.11 Information amendment (info not covered under modules 2-5
- 1.11.1 Quality information amendment
- 1.11.2 Safety information amendment
- 1.11.3 Efficacy information amendment

## Module 1 TOC

- 1.12 Other correspondence
- 1.12.1 Pre IND correspondence
- 1.12.2 Request to charge
- 1.12.3 Notification of charging under treatment IND
- 1.12.4 Request for comments and advice on an IND
- 1.12.5 Request for a waiver
- 1.12.6 Exemption from informed consent for emergency research
- 1.12.7 Public disclosure statement for emergency care research
- 1.12.8 Correspondence regarding emergency care research

## Module 1 TOC

- 1.12.9 Notification of discontinuation of clinical trial
- 1.12.10 Generic drug enforcement act statement
- 1.12.11 Basis for submission statement
- 1.12.13 Comparison of generic drug and reference listed drug
- 1.12.14 Request for waiver for in vivo studies
- 1.12.15 Environmental assessment
- 1.12.16 Request for waiver of in vivo bioavailability studies
- 1.12.17 Field alert reports

## Module 1 TOC

- 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
- 1.13.6 Summary of microbiological changes

## Module 1 TOC

- 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 history
- 1.13.11 Distribution data
- 1.13.12 Status of postmarketing study commitments
- 1.13.13 Status of other postmarketing studies
- 1.13.14 Log of outstanding regulatory business

## Module 1 TOC

- 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

## Module 1 TOC

- 1.14.2 Final labeling
- 1.14.2.1 Final carton and 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

## Module 1 TOC

- 1.14.4 Investigational drug labeling
- 1.14.1.1 Investigator’s brochure
- 1.14.1.2 Investigational drug Labeling
- 1.14.5 Foreign labeling
- 1.15 Promotional material
- 1.16 Risk management plans

## Summary

- Module 1 sets the regulatory and legal framework for applications and subsequent submissions
- Match information to appropriate heading