1. Market Research

Regulatory Trends in the US Life Sciences Industry

  • May 2014
  • 36 pages
  • Frost & Sullivan
Report ID: 2148682

Summary

Table of Contents

Efficiency of FDA Review Process Expedites Access to Care

This market insight provides an analysis of the regulatory trends occurring in the US life sciences market. Included in this deliverable is an analysis of the new molecular entities (NMEs) approved by the US Food and Drug Administration and predictions for 2014. Trends are showing that the Food and Drug Administration is moving towards greater efficiency and expedited review periods which leads to faster access to care.

Executive Summary

- The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) declined in 2013 compared to previous years. This was a result of
fewer drug regulatory submissions by pharmaceutical and biotechnology companies.
- The efficiency of the US FDA review of drug submissions continues to improve as a result of its expedited review designations consisting of fast track, breakthrough, priority review, and accelerated approval.
- Fewer drugs with a new and unique mechanism of action for treating a medical condition are launching in the US market. This results in fewer first-in-class designations.
- Drugs that treat orphan diseases continue to be a focus for research and development by pharmaceutical and biotechnology companies. Approximately 1/3 of new NME approvals were for orphan diseases in 2012 and 2013.
- There continues to be a lack of a clear biosimilar regulatory pathway in the US market.
- The social media industry is becoming more tightly regulated by the FDA in order to prevent false promotions by pharmaceutical and biotechnology companies.

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 60 Million searchable statistics with tables, figures & datasets
  • More than 25,000 trusted sources
  • Single User License — provides access to the report by one individual.
  • Department License — allows you to share the report with up to 5 users
  • Site License — allows the report to be shared amongst all employees in a defined country
  • Corporate License — allows for complete access, globally.

Veronica helps you find the right report:

Testimonials

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

We were impressed with the support that ReportLinker’s research specialists’ team provided. The report we purchased was useful and provided exactly what we want.

Category Manager at
Ikea

ReportLinker gave access to reliable and useful data while avoiding dispersing resources and spending too much time on unnecessary research.

Executive Director at
PwC Advisory

The customer service was fast, responsive, and 100% professional in all my dealings (...) If we have more research needs, I'll certainly prioritize working with ReportLinker!

Scott Griffith

Vice President Marketing at
Maurice Sporting Goods

The research specialist provided prompt, helpful instructions for accessing ReportLinker's product. He also followed up to make sure everything went smoothly and to ensure an easy transition to the next stage of my research

Jessica P Huffman

Research Associate at
American Transportation Research Institute

Excellent customer service. Very responsive and fast.

Director, Corporate Strategy at
Ingredion

I reached out to ReportLinker for a detailed market study on the Air Treatment industry. The quality of the report, the research specialist’s willingness to solve my queries exceeded my expectations. I would definitely recommend ReportLinker for in-depth industry information.

Mariana Mendoza

Global Platform Senior Manager at
Whirlpool Corporation

Thanks! I like what you've provided and will certainly come back if I need to do further research works.

Bee Hin Png

CEO at
LDR Pte Ltd

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

ref:plp2014

Reportlinker.com © Copyright 2017. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.