Accelerating Drugs to Market Size, Share, Trends and Future

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Accelerating Drugs to Market - In Search of
Opportunity Along the Drug Development Approval
Pathway
(Type, Mode of action, Crop Type and Geography) -
Size, Share, Global Trends, Company Profiles,
Demand, Insights, Analysis, Research, Report,
Opportunities, Segmentation and Forecast, 2013 -
2020
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Published on Oct 2014
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Report Overview

• The commercial life of a drug and the sales
  trajectory achieved are dependent on a multitude
  of factors. One critical factor in achieving
  success is the ability to bring a product to
  market quickly to gain competitive advantages and
  to start recouping development costs. From
  product concept to market, there are a number of
  potential areas of opportunity for accelerating a
  drug through to FDA approval. Many initiatives
  tie to scientific and technological innovations
  in the research and development realm while
  others are tied to the regulatory pathway.
• The four main FDA mechanisms that can play a role
  in speeding drugs to market are Accelerated
  Approval, Priority Review, Fast Track and orphan
  designation. All of these were designed with the
  intention of facilitating development of drugs
  that address critical needs.
• Scope
• - Background, benefits and regulations related to
  accelerated approval
• - Overview of related policies and programs
• - Key takeaways and considerations- Future
  outlook
• Read More At http//www.researchbeam.com/acceler
  ating-drugs-to-in-search-of-opportunity-along-the-
  drug-development-and-approval-pathway-market

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Table of Content

• Executive Summary
• Introduction
• Where are there opportunities to influence how
  quickly a drug reaches the market?
• Accelerated Approval
• Background on the regulation
• Benefits and risks to manufacturers
• EU regulation Conditional Marketing
  Authorization
• Priority Review
• Background on the policy
• Impact on drug approval times
• Priority Review Vouchers
• EU regulation Accelerated Assessment

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Table of Content
Fast Track Background on the program Influence
on drug development approval timelines Consider
ations for manufacturers Orphan Drug
Designation Background on the regulation Advanta
ges and risks in orphan drug development EU
regulation Orphan Designation Key Takeaways
Considerations Appendix Enquire At
http//www.researchbeam.com/accelerating-drugs-to-
in-search-of-opportunity-along-the-drug-developmen
t-and-approval-pathway-market/enquire-about-report

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in-search-of-opportunity-along-the-drug-developmen
t-and-approval-pathway-market
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