Bharat Book Bureau Provides the Treding Market Research Report on "Drug Development in Rare Diseases: Focus on Clinical Trials and the Regulatory Landscape" under Life Sciences Category. The report offers a collection of superior market researach, market analysis, competitive intelligence and Market reports.

Report Scope:

This report analyzes the regulatory framework for the Clinical Trials Of Orphan Drugs in rare and orphan diseases. The report also analyzes the trends and characteristics of clinical trials conducted on rare diseases from 1999-2018, using information from various sources. This report covers an overview of the global orphan drugs market and its competitive landscape.

Report Includes:

- An overview of the drug development in rare diseases with special focus on clinical trial and regulatory landscape
- Detailed description of different kinds of orphan drugs and a comparative assessment on biological and chemical or non-biological orphan drugs
- Discussion on Orphan Drug Act; insights into general framework for the regulation of drugs and biologics, and regulations for clinical trials of orphan designated drugs
- H-ighlights of technological advances and innovations in genetic manufacturing technologies and information on terms such as generic competition, patent expirations, premium pricing and information on orphan drug designation applications

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Summary:

The orphan drug industry is gaining importance as a significant and rewarding market in the pharmaceutical and biotech sectors. Technological and scientific innovations in specific drug discovery pathways as well as major developments in genetics are cultivating growth in this industry. Report’s objective in conducting this report is to provide detailed information on drug development in rare diseases. This report provides a comprehensive analysis and examines the future direction of these drugs as an important means for the treatment of orphan and rare diseases.

Table of Contents
- Chapter 1 Introduction
- Study Goals and Objectives
- Reasons for Doing this Study
- Scope of Report
- Information Sources
- Methodology
- Analyst's Credentials
- Research Reports
- Chapter 2 Definitions and Background
- Types of Orphan Drugs
- Biological Orphan Drugs
- Chemical or Non-biological Orphan Drugs
- Global Definitions of Rare Diseases by Country/Region
- U.S.
- EU
- Taiwan
- Japan
- Australia
- Chapter 3 FDA Regulation of Clinical Trials on Orphan Designated Drugs
- General Framework of the Regulation of Drugs and Biologics
- Accelerated Approvals
- Fast Track Designation
- Breakthrough Designation
- Priority Review
- Controlled Substances Act
- Special Protocol Assessments
- New Surveillance and Safety Requirements
- Regulation of Clinical Trials on Orphan Designated Drugs
- Content and Format of a Request for Written Recommendations
- Providing Written Recommendations
- Refusal to Provide Written Recommendations
- Orphan Drug Designation
- Orphan Drug Exclusive Approval
- Chapter 4 European Regulation of Clinical Trials on Orphan Designated Drugs
- European Orphan Regulation
- Legal Framework
- Applying for Orphan Designation
- Orphan Drug Designation Application Challenges and Maintenance
- Demonstrating Significant Benefit
- Timelines

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