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cobu5zaj6xm
Wysłany: Sob 10:17, 02 Kwi 2011
Temat postu: air jordan ajf 5 Aarkstore Enterprise women jorda
The number of new molecular entities approved in the US each year has declined from 36 to 18 since 2004
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, despite a sustained increase in the amount of clinical trials conducted.
Biosimilar approval structures in the EMEA are significantly more comprehensive than those of the FDA. Europe is now becoming the global center for biosimilar development and production.
For more information, please contact :
/reports/Drug-Approval-Trends-at-the-FDA-and-EMEA-Process-improvements-heightened-scrutiny-and-industry-response-14421.html
The EMEA is approving fewer products than the FDA even though processing speed and volume have been significantly improved. System reforms include reduced review times, faster approvals for innovative drugs and relaxed requirements in pediatric trials.
The FDA and EMEA are asking for more data in drug applications that pose heightened safety concerns, although there have been no official changes in overall drug approval standards.
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Drug Approval Trends at the FDA and EMEA: Process improvements, heightened scrutiny and industry response
Business Intelligence for the Pharmaceutical Industry
The portfolio of healthcare management reports is designed to help you make well informed and timely business decisions. We understand the problems facing today's pharmaceutical and healthcare executives when trying to drive your business forward, and appreciate the importance of accurate, up-to-date, incisive product
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, market and company analysis. We help you to crystallize your business decisions.
The strength of our research and analysis is derived from access to unparalleled databases and libraries of information and the use of proprietary analytic techniques. Reports are authored by independent experts and contain findings garnered from dedicated primary research. Our authors' leading positions secure them access to interview key executives and to establish which issues will be of greatest strategic significance for the industry.
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, new business opportunities and strategic insight.
Some key findings from this />
Information about new drug candidates is being increasingly shared by the FDA and EMEA as globalization continues throughout the pharma industry. Such convergence is prominent in the orphan drugs area, where evaluations require considerable resources.
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