Performance Improvement 2009. What Factors Influence New Drug Application First-Cycle Approvals; What Initiatives Impact These Factors?

01/01/2009

This study examined efforts to achieve specific goals to improve the effectiveness and efficiency of review of new drug applications and biologic license applications. Several of these goals focused on improving the review process activities occurring between initial submission of the application and subsequent FDA action regarding the application.

The study found that the Filing Review Notification, or 74-Day Letter, communicated deficiencies to sponsors. Also, priority review designation given to applications for products that offered major advances in treatment or provided a treatment where no adequate therapy exists, had the most significant impact on first-cycle approval rates. Applications were more likely to be approved in the first cycle if a major deficiency was identified pre-submission than if major deficiencies were identified during the review. Applications for which no major deficiency was identified either pre-submission or during the review had a high first-cycle approval rate. Products with a novel mechanism of action targeting life-threatening conditions had a greater first-cycle approval rate. Applications that complied with most or all of the assessed good review manufacturing procedures activities had the highest first-cycle approval rates. Researchers made two key recommendations: FDA should continue with good review manufacturing procedures implementation, ensuring adoption of good review manufacturing procedures activities and timeframes; and, FDA should continue to use the 74-Day Letter to communicate application deficiencies early in the review process.

Report Title: Independent Evaluation of FDA's First Cycle Review Performance - Final Report http://www.fda.gov/oc/pdufa3/firstcyclerept08/default.htm
Agency Sponsor: FDA, Food and Drug Administration
Federal Contact: William Hagan, 301-827-5292
Performer: Booz Allen Hamilton
PIC ID: 8950

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