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Findings in the 156 page Report include:
• The total number of new drugs approved by the FDA and EMEA dropped to 121 in 2005. Approvals will increase to 201 by 2010, at an AAGR of 10.7%.
• There were about 1,934 recalls in 2003 (including all batch recalls and product recalls), and the rate increased to 2,072 in 2005. It is expected to increase at an AAGR of 5.1% to reach 2,616 by 2010.
• The most recalls in 2005 were seen in pain management, anti-inflammatory, anesthetics and ant allergic drugs.
• Spending in the regulatory and surveillance industry is expected to rise at an AAGR of 10% to reach $265 billion by 2010, with the emphasis on oncology, cardiovascular, hormonal, contraceptive and mental disorder drug markets.
Summary of the Report:
• Coverage of regulatory environments worldwide
• Analyses of each market by drug category
• Discussions of the process and time involved in approval - NDA, BLA, EMEA
• Post marketing issues
• Market trends with historical perspectives
• Five-year market projections for new approvals and recalls
• Drug safety spending data
• Company profiles.
Content:
Introduction
Executive Summary
Overview
Types Of Drug Regulatory Authorities In The World
Types Of Regulations Governed
The Approval System
Investigational New Drugs
The New Drug Application (NDA) And The Biologic License Application (BLA)
Products Approved By Emea
Post marketing Issues
Drug Safety Spending
Company Profiles
Appendix
List Of Figures
Pharmaceutical Regulatory Industry is available in PDF format from Report Buyer. For more information go to: http://www.reportbuyer.com/
Report Buyer product ID: BCC00072
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