NUMBER 312.7(d)eCTD/STFHeading MODULENUMBER 11.12.2 TITLE ChargingforandcommercializationofinvestigationaldrugsWaivers TITLE RequesttoCharge 312.10 11 1.12.51.1.1 RequestforawaiverApplicationform:FDAform1571N/APatentInformation 5 312.23(a)(1)Coversheet(FormFDA1571)312.23(a)(2)TableofContents...
Portable Document Format Specification v4.1— 文件格式规范:本指南详细介绍了向美国FDA提交的eCTD中有关PDF文件的相关要求,包括版本、安全设置、字体、页面方向、大小、页边距等细节上的要求。 The comprehensive Table of Contents Headings and Hierarchy: 本指南是一份完整全面的内容标题和层级表。直观的列出了模块1...
The comprehensive Table of Contents Headings and Hierarchy: 本指南是一份完整全面的内容标题和层级表。直观的列出了模块1至5的结构和呈现形式。 TheeCTD Backbone Files Specification for Module 1:模块1的eCTD主干文件规范,本文件时FDA规定的模块1的eCTD主干文件技术规范。 Specification foreCTD Validation Criteria...
文件格式规范则详细介绍了向美国FDA提交eCTD中PDF文件的要求，包括版本、安全设置、字体、页面方向、大小、页边距等细节。全面的标题和层级表（Table of Contents Headings and Hierarchy）是一份完整的内容组织表，直观地展示了模块1至5的结构和呈现形式。eCTD主干文件规范（eCTD Backbone Files Specification ...
The comprehensive Table of Contents Headings and Hierarchy: 本指南是一份完整**的内容标题和层级表。直观的列出了模块1至5的结构和呈现形式。 TheeCTD Backbone Files Specification for Module 1:模块1的eCTD主干文件规范,本文件时FDA规定的模块1的eCTD主干文件技术规范。
The comprehensive Table of Contents Headings and Hierarchy: 本指南是一份完整全面的内容标题和层级表。直观的列出了模块1至5的结构和呈现形式。 TheeCTD Backbone Files Specification for Module 1:模块1的eCTD主干文件规范,本文件时FDA规定的模块1的eCTD主干文件技术规范。
Supplement; updated hyperlinks which were no longer working Version 2.4 The eCTD Backbone Files Specification for Module 1 TABLE OF CONTENTS TABLE OF CONTENTS 1 INTRODUCTION 1 I. USE OF ATTRIBUTES 1 II. START OF THE MODULE 1 eCTD BACKBONE FILE 2 III. ADMIN ELEMENTS 3 A. Applicant-info ...
│├── 2.1 Overall Table of Contents │├── 2.2 Quality Overall Summary │├── 2.3 Nonclinical Overview │└── ... ├── Module 3: Quality │├── 3.1 Pharmaceutical Quality │├── 3.2 Nonclinical Study Reports │├── 3.3 Clinical Study Reports │└── ... ├── Module...
Bookmarks should include all tables, figures, publications, other references, and appendices even if these items are not in the table of contents. These bookmarks are essential for the efficient navigation through documents. The use of no more than 4 levels in the hierarchy is recommended, but ...
Types of Submissions That May Qualify for a Short-Term Waiver From the eCTD Requirement Described in This Guidance • Added section to include the criteria to qualify for a waiver and the instructions on how to submit a request for a short-term waiver TABLE OF CONTENTS I. INTRODUCTION 1 ...