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市場調查報告書

美國的醫藥品/生物科技產業上的法規趨勢

Regulatory Trends in the US Pharma/Biotech Industry

出版商 Frost & Sullivan 商品編碼 325414
出版日期 內容資訊 英文 37 Pages
商品交期: 最快1-2個工作天內
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美國的醫藥品/生物科技產業上的法規趨勢 Regulatory Trends in the US Pharma/Biotech Industry
出版日期: 2015年02月26日 內容資訊: 英文 37 Pages
簡介

本報告提供美國的醫藥品/生物科技產業上的法規趨勢相關分析、美國FDA核準的新分子化合物 (NME) 的分析與預測、孤兒藥認證、First-in-Class指定、新藥的迅速核准,及最初循環許可等資料彙整,為您概述為以下內容。

摘要整理

  • 主要調查結果

美國FDA申請、認證的新分子化合物 (NME) 分析

  • NME趨勢表示藥事申請、認證大幅增加
  • 孤兒藥認證的增加
  • First-in-Class指定的增加
  • 大多數已批准的NME接受新藥的迅速核准
  • 第一週期認證高數量持續
  • 口腔療法由醫藥品/生物科技產業繼續佔多數
  • NME認證

Frost & Sullivan的預測

關於Frost&Sullivan

目錄
Product Code: 9AB9-00-1C-00-00

Efficiency of the FDA Review Process Expedites Access to Care

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

Executive Summary

  • 1. Key Findings

Analysis of 2014 New Molecular Entities US FDA Filings and Approvals

  • 1. NME Trends Show a Significant Increase in Regulatory Filings and Approvals
  • 2. Increase in Orphan Drug Approvals
  • 3. Increase in First-in-class Designation
  • 4. Most Approved NMEs Evaluated as an Expedited Review
  • 5. High Number of First Cycle Approval Continues
  • 6. Oral Therapies Continue Dominating the Pharma/Biotech Industry
  • 7. NMEs Approved in 2014
  • 8. NMEs Approved in 2014 (continued)
  • 9. NMEs Approved in 2014 (continued)
  • 10. NMEs Approved in 2014 (continued)
  • 11. NMEs Approved in 2014 (continued)
  • 12. NMEs Approved in 2014 (continued)
  • 13. NMEs Approved in 2014 (continued)
  • 14. NMEs Approved in 2014 (continued)
  • 15. NMEs Approved in 2014 (continued)
  • 16. NMEs Approved in 2014 (continued)
  • 17. NMEs Approved in 2014 (continued)
  • 18. NMEs Approved in 2014 (continued)
  • 19. NMEs Approved in 2014 (continued)
  • 20. NMEs Approved in 2014 (continued)
  • 21. NMEs Approved in 2014 (continued)

Frost & Sullivan Predictions for 2015

  • 1. Frost & Sullivan Predictions for 2015
  • 2. Legal Disclaimer

The Frost & Sullivan Story

  • 1. The Frost & Sullivan Story
  • 2. Value Proposition: Future of Your Company & Career
  • 3. Global Perspective
  • 4. Industry Convergence
  • 5. 360° Research Perspective
  • 6. Implementation Excellence
  • 7. Our Blue Ocean Strategy
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