FINDINGS: Independent Evaluation of FDA's First Cycle Review Performance – Final Report
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).
|Cohort||Number of Applications||Analyses||Data Collection Method|
|Action Packages||Public Data Sources||FDA Application Review Systems|
|Overall Study Cohort||185||
|Prospective Analysis Cohort||85||
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.