Regulatory Trends in the US Life Sciences Industry

Efficiency of FDA Review Process Expedites Access to Care

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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

Regulatory Trends in the US Life Sciences IndustryExecutive SummaryExecutive SummaryAnalysis of 2013 NME US FDA Filings and ApprovalsNME Trends Show Decline in Regulatory Filings and ApprovalsOrphan Drug Designation Remains StagnantDecline in First-in-class DesignationMost Approved NMEs Undergo an Expedited ReviewHigh Number of First Cycle Approval ContinuesNMEs Approved in 2013NMEs 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 2014Frost & Sullivan Predictions for 2014Legal DisclaimerThe Frost & Sullivan StoryThe Frost & Sullivan StoryValue Proposition: Future of Your Company & CareerGlobal PerspectiveIndustry Convergence360º Research PerspectiveImplementation ExcellenceOur Blue Ocean Strategy




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