Efficiency of the FDA Review Process Expedites Access to Care
26-Feb-2015
Global
Market Research
9AB9-00-1C-00-00
LS00070-GL-MR_16911
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.
Key Findings
NME Trends Show a Significant Increase in Regulatory Filings and Approvals
Increase in Orphan Drug Approvals
Increase in First-in-class Designation
Most Approved NMEs Evaluated as an Expedited Review
High Number of First Cycle Approval Continues
Oral Therapies Continue Dominating the Pharma/Biotech Industry
NMEs Approved in 2014
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)
NMEs Approved in 2014 (continued)
Frost & Sullivan Predictions for 2015
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| Deliverable Type | Market Research |
|---|---|
| No Index | No |
| Podcast | No |
| Author | Jennifer Lazar |
| WIP Number | 9AB9-00-1C-00-00 |
| Is Prebook | No |
Regulatory Trends in the US Pharma/Biotech Industry
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