The study cohort for the planned review timelines analysis consisted of all 44 original applications (26 NME NDAs and 18 BLAs) that were received in FY09 (October 1, 2008 – September 30, 2009) and had reached the milestone date for sending the filing communication. The cohort was defined by FDA in its annual performance report for PDUFA, and included applications submitted to and reviewed by both CDER (33 applications) and CBER (11 applications). CBER’s Regulatory Information Management Staff and CDER’s Division of Business Analytics and Reporting provided Booz Allen with the identity of the applications in the cohort, as well as their success or failure in meeting the two planned review timelines milestones, summarized in Exhibit 1.
Exhibit 1. Study Cohort Adherence to Planned Review Timelines Milestones
* "Pending" applications included planned review timelines in the filing communication, but had not reached the communicated dates by the end of FY 09; the review cycle was extended by three months due to major amendments for two applications.
Sources: FY 2009 Performance Report to Congress and the President on the Prescription Drug User Fee Act, FDA-provided data from CBER and CDER
Of the applications in the cohort, 86% (38/44) included the Planned Review Timelines in the filing communication to the applicant. The remaining 14% (6/44) were the subject of further analysis, described below, to determine the explanation for the failure to include the milestone dates in the filing communication. Among the 38 applications in the cohort that included the planned review timelines in the filing communication, 20 could not be assessed for compliance in meeting those milestone dates, either because the dates were not reached prior to the end of FY09 (“pending”) or because the communicated dates were no longer applicable due to the submission of a major amendment. The remaining 18 applications were assessed for compliance with the communicated timelines, and 61% (11/18) did not meet this milestone date and were the subject of additional analysis to determine the root cause of non-compliance.
Data on each application for the root cause analysis were gathered from FDA documents, RPM interviews and applicant interviews. FDA documents were the first source for basic information about product and review characteristics (e.g., priority/standard review designation, AC meeting, number of amendments submitted, and approval or complete response action). These data were analyzed and hypotheses were developed regarding the explanation for failure to adhere to the planned review timelines milestones. Interviews were conducted with RPMs for 4 of the 6 applications that did not include the planned review timelines in the filing communication, and 16 of the 18 applications for which adherence to the communicated timelines was evaluated. Standard questions were asked of each RPM using a brief interview guide, shown in Appendix C, to collect additional information to test the hypotheses. A structured interview guide was also employed for interviews of 13 applicants, and is included in Appendix D.
 According to the GRMPs guidance, the filing communication should be sent to the applicant by day 74 after NDA/BLA receipt.
 FY 2009 Performance Report to the President and Congress for the Prescription Drug User Fee Act.
 In accordance with the PDUFA IV performance goals, a 7-day grace period was allowed from the target date for initiating communications with the applicant.