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U.S. Department of Health and Human Services

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FINDINGS: Independent Evaluation of FDA's First Cycle Review Performance – Final Report

Table of Contents

STUDY OVERVIEW

The following sections present the analysis and implications from the five-year study of factors that contribute to or detract from FDA’s ability to make a decision regarding the product application on first-cycle.  Major findings are described by hypothesis categories:  Product and Disease Characteristics, GRMPs Compliance, Issues and Communication, Sponsor Characteristics and FDA Characteristics.  In most instances, our findings are representative of the Overall Study Cohort.  However, when there was a notable difference between the findings from the FY2002– FY2004 and FY2005 – FY2007 cohorts, we present these findings by cohort.  In addition, there are some analyses that were conducted using a subset of the Overall Study Cohort, based on availability and quality of data (Exhibit 6).


 Exhibit 6. Product Application Cohorts, Data Sources, and Analyses [8]

Cohort Number of Applications Analyses Data Collection Method
Action Packages Public Data Sources FDA Application Review Systems
Overall Study Cohort 185
  • Review Designation
  • Sponsor Characteristics
  • Product Characteristics
  • Pre-Submission Meetings
  • Filing Review Notification
  • Advisory Committee Meetings
  • Major Review Deficiencies
  • Postmarketing Commitments
  • Review Office Characteristics
  • Manufacturing Inspection
     
Prospective Analysis Cohort 85
  • Total Review Communications
  • GRMPs Impact
  • FDA Staffing Changes
     

Link to detailed description

The quantitative and qualitative data collected through observation of application review team meetings, review team input, sponsor interviews, industry focus groups, and FDA focus groups were used in the development of findings and recommendations.  Detailed findings for the five categories of hypotheses tested are listed in the following sections.


Product and Disease Characteristics