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The Innovation Imperative in the Safety First Era

For the FDA’s new drug review process, much can change in a year. And during the last 12 months, the key metrics in the pharma industry’s continuing quest to obtain FDA approval for its new drugs have shifted considerably, and with them the pharma industry’s expectations for new drug review outcomes, particularly in the near- and medium-term.

Our new executive briefing, The Innovation Imperative in the Safety First Era, highlights and discusses several emerging trends and metrics with direct implications for drug reviews and approvals today:

• Pending NDAs surge over the last year, but have NME submissions as well?
• How has the increased safety scrutiny at FDA affected new drug review times and outcome patterns?
• If first-cycle NDA approval rates have steadied, why have approval rates for priority NDAs stumbled recently?
• The real-world implications of overdue NDA reviews on first-cycle approval rates.
• Why priority-rated drugs continue to have advantages in the drug review process despite emerging review outcome patterns.
• Maximizing effort and focus on initial NDA and anticipating safety issues are more critical than ever for successful first-cycle review outcomes.

If, after reading our new executive briefing, you would like to see the detailed findings of our recent study of new drug review trends and outcomes (including findings more directly pertinent to your products and therapeutic area focus), please contact Mark Mathieu, Director Strategic Research, PAREXEL Consulting at mark.mathieu@parexel.com.