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市場調查報告書

美國的生命科學產業上法規趨勢

Regulatory Trends in the US Life Sciences Industry

出版商 Frost & Sullivan 商品編碼 304533
出版日期 內容資訊 英文 36 Pages
商品交期: 最快1-2個工作天內
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美國的生命科學產業上法規趨勢 Regulatory Trends in the US Life Sciences Industry
出版日期: 2014年05月23日 內容資訊: 英文 36 Pages
簡介

本報告提供美國的生命科學產業上法規趨勢的相關調查、美國的FDA認可的、預計今年認證的新化合物(NME)的分析。

第1章 美國的生命科學產業上法規趨勢

摘要整理

新化合物(NME) 美國FDA的申請、認證:分析

  • NME趨勢顯示法規申請、認證的減少
  • 孤兒藥指定持續停頓
  • First-in-Class指定的減少
  • 多數核準的NME接受新藥的迅速核准
  • 第一周期認證持續多數量
  • NME認證

Frost & Sullivan 的預測

關於Frost&Sullivan

目錄
Product Code: 9AB9-00-01-00-00

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.

Table of Contents

1. REGULATORY TRENDS IN THE US LIFE SCIENCES INDUSTRY

Executive Summary

  • 1. Executive Summary

Analysis of 2013 NME US FDA Filings and Approvals

  • 1. NME Trends Show Decline in Regulatory Filings and Approvals
  • 2. Orphan Drug Designation Remains Stagnant
  • 3. Decline in First-in-class Designation
  • 4. Most Approved NMEs Undergo an Expedited Review
  • 5. High Number of First Cycle Approval Continues
  • 6. NMEs Approved in 2013
  • 7. NMEs Approved in 2013 (continued)
  • 8. NMEs Approved in 2013 (continued)
  • 9. NMEs Approved in 2013 (continued)
  • 10. NMEs Approved in 2013 (continued)
  • 11. NMEs Approved in 2013 (continued)
  • 12. NMEs Approved in 2013 (continued)
  • 13. NMEs Approved in 2013 (continued)
  • 14. NMEs Approved in 2013 (continued)
  • 15. NMEs Approved in 2013 (continued)
  • 16. NMEs Approved in 2013 (continued)
  • 17. NMEs Approved in 2013 (continued)
  • 18. NMEs Approved in 2013 (continued)
  • 19. NMEs Approved in 2013 (continued)

Frost & Sullivan Predictions for 2014

  • 1. Frost & Sullivan Predictions for 2014
  • 2. Legal Disclaimer

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