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Regulatory Trends in the US Life Sciences Industry

  • May 2014
  • -
  • Frost & Sullivan
  • -
  • 36 pages

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.

Table Of Contents

Regulatory Trends in the US Life Sciences Industry
REGULATORY TRENDS IN THE US LIFE SCIENCES INDUSTRY

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

Frost and Sullivan Predictions for 2014

Frost and Sullivan Predictions for 2014
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