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
Request a Free Sample Copy Drug Development Market Report@ https://www.bharatbook.com/marketreports/sample/reports/2288657
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
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vidhyanigam98 Joined: November 9th, 2019 Articles Posted: 315
