Applied Clinical Trials-10-01-2008

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Applied Clinical Trials

An in depth look at industry's reaction to FDAAA, its requirements, submitting the results, and meeting the deadline.

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Safety Put Into Practice

Applied Clinical Trials

From pre- to postmarketing, safety monitoring must be a priority that's handled with knowledgeable care.

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R&D In a Virtual World

Applied Clinical Trials

A purely empirical approach to drug development may allow for evaluation of the overt factors that impact the balance of benefit and risk, but it will never uncover all potential scenarios for which companies are now being held accountable.

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Applied Clinical Trials

By defining hurdles to registration, emerging companies benefit from early regulatory guidance.

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Applied Clinical Trials

After almost a decade of dim progress in drug development, R&D is finally making a come back, according to current data published in Parexel International's, "The U.S. Drug Approval Trends and Yearbook 2008/2009."