# Presentation: 873861

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

*June 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

## Document Processing

- Submit all electronic submissions to
- New Drugs and Biologic applications assigned to CDER: Central Document Room
- Generic Drugs: OGD Document Room

## Biologic Products Assigned to CDER

- Monoclonal antibodies for *in-vivo* use
- Proteins intended for therapeutic use, including cytokines, enzymes, and other novel proteins
- Immunomodulators
- Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease or otherwise alter the production of hematopoietic cells *in vivo*

## Not Transferred

- Office of Blood Research and Review
- Traditional blood products
- Office of Vaccines Research and Review
- Traditional prophylactic vaccines
- Proteins intended to induce new immune responses, even therapeutic responses, e.g., Alzheimer’s vaccine
- Cancer vaccines
- Office of Cell Therapy and Gene Therapy
- Live cell vaccines and cellular therapies
- Virally-vectored and naked-DNA gene therapies

## Document Processing

- CDER Central Document Room:
- Identify the division if you know it and for biologics applications add:

**Food and Drug Administration**
**Center for Drug Evaluation and Research**
**5901-B Ammondale Road**
**Beltsville, Maryland  20705-1266**

**Attn: Therapeutic Biologics Document Room Staff**

## 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 documents

- 1.1 Forms– not all forms are included in this section
- 3542 and 3542A (Patent certifications)
- 1572 (Investigator information)
- 1.2 Cover letters– still needed!
- 1.4.4 Cross reference to other applications *and previously submitted information*

## Module 1 documents

- First consider headings in Modules 2-5
- 1.6.2 Meeting background materials
- 1.8 Special Protocol Assessment request
- 1.10 Dispute Resolution
- 1.11 Information amendment (info not covered under modules 2-5)
- 1.13 Annual report

## Module 1: Labeling

- Targeted Product Profile (TPP)
- 1.14.4.1 Investigator’s Brochure
- SPL
- Must be placed in the SPL folder
- Link to the appropriate subheading in the TOC
- 1.14.1.3 Draft labeling text
- 1.14.2.3 Final labeling text

## Summary

- Module 1 sets the regulatory and legal framework for applications and subsequent submissions
- Documents in Module 1 provide information important to document processing
- Be sure to match information to appropriate heading
- Send submissions to the correct address