Regulatory Trends in the US Pharma/Biotech Industry

Efficiency of the 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 pharma/biotech industry for 2014. Included in this deliverable is an analysis of the new molecular entities (NME) approved by the US Food and Drug Administration in 2014 and predictions for 2015. Trends are showing that the US Food and Drug Administration is moving towards greater efficiency and expedited review periods, which will lead to faster access to care.

Table of Contents

Regulatory Trends in the US Pharma/Biotech IndustryExecutive SummaryKey FindingsAnalysis of 2014 New Molecular Entities US FDA Filings and ApprovalsNME Trends Show a Significant Increase in Regulatory Filings and ApprovalsIncrease in Orphan Drug ApprovalsIncrease in First-in-class DesignationMost Approved NMEs Evaluated as an Expedited ReviewHigh Number of First Cycle Approval ContinuesOral Therapies Continue Dominating the Pharma/Biotech IndustryNMEs Approved in 2014NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)NMEs Approved in 2014 (continued)Frost & Sullivan Predictions for 2015Frost & Sullivan Predictions for 2015Legal 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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