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Regulatory Trends in the US Life Sciences Industry
Regulatory Trends in the US Life Sciences Industry
Efficiency of FDA Review Process Expedites Access to Care
RELEASE DATE
23-May-2014
23-May-2014
REGION
Europe
Europe
Research Code: 9AB9-00-01-00-00
SKU: LS00068-EU-MR_16909
$1,500.00
In stock
SKU
LS00068-EU-MR_16909
Description
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.
Table of Contents
Executive Summary
- Executive Summary
Analysis of 2013 NME US FDA Filings and Approvals
- NME Trends Show Decline in Regulatory Filings and Approvals
- Orphan Drug Designation Remains Stagnant
- Decline in First-in-class Designation
- Most Approved NMEs Undergo an Expedited Review
- High Number of First Cycle Approval Continues
- NMEs Approved in 2013
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
- NMEs Approved in 2013 (continued)
Frost & Sullivan Predictions for 2014
- Frost & Sullivan Predictions for 2014
- Legal Disclaimer
The Frost & Sullivan Story
- The Frost & Sullivan Story
- Value Proposition: Future of Your Company & Career
- Global Perspective
- Industry Convergence
- 360º Research Perspective
- Implementation Excellence
- Our Blue Ocean Strategy
Popular Topics
Biomarkers will certainly change the way healthcare is provided. They are being increasingly used in early drug development and for clinical use as well, boosting their demand. The penetration of biomarkers in various therapeutic applications, the impact of market trends and dynamics are analysed in this study. This research service offers market overview, Market Engineering measurements, revenue forecasts, company profiling and key trends for the market and its segments, namely, genomics, proteomics, metabolomics and imaging biomarkers.
| No Index | Yes |
|---|---|
| Podcast | No |
| Author | Jennifer Lazar |
| WIP Number | 9AB9-00-01-00-00 |
| Is Prebook | No |