Notes on the FY 2000 PDUFA Performance Report to Congress

1. This report uses the terms PDUFA I and PDUFA II to distinguish between the original Prescription Drug User Fee Act of 1992 and the Act as reauthorized and amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA) respectively. Where no distinction is needed or where the reference is obvious, the term PDUFA is used.
2. Previous PDUFA Performance Reports mentioned a pre-PDUFA approval rate of less than 60 percent. The source for this information was the United States General Accounting Office [FDA Drug Approval: Review Time Has Decreased in Recent Years (GAO/PEMD-96-1), October 1995]. Since 1995, additional NDAs from pre-PDUFA submission cohorts have been approved. A recent analysis by the Center for Drug Evaluation and Research now puts the pre-PDUFA approval rate at approximately 66 percent.
3. Although the last approvals for FY 99 submissions (as well as for earlier years) have not yet occurred, the median statistic can be estimated from approvals to date and estimates of the percent of submissions that will ultimately be approved.
4. The count of FY 00 submissions assumes that all submissions received in the last two months of FY 00 are filed. When FDA files a submission, it is deemed "complete" by PDUFA definition. FDA makes a filing decision within 60 days of an original application's receipt. All calculations of PDUFA review times are made, however, from the original receipt date of the filed application.
5. The term NME in this report refers exclusively to NMEs that are NDAs. For FDAMA purposes, BLAs are considered to be equivalent to NMEs; however, workload and performance statistics for BLAs are reported separately. The counts of NMEs in the workload table are of 'discrete,' filed NMEs. CDER often receives multiple submissions for the same new molecular entity, for different dosage forms for example. All are initially designated as NMEs, but, when the first of the multiples is approved, the others are re-designated as non-NMEs. In FY 00, CDER designated 36 filings as NMEs initially (17 priority, 19 standard). Only 35 of these are 'discrete' (17 priority, 18 standard).
6. The statute allows three additional months for review of original NDA and BLA submissions that involve major amendments received within the last three months of their usual review intervals.
7. Includes those with late actions and those still pending whose goal date has passed and which have not had actions.
8. Includes actions that are pending within goal, as well as those whose goal date has passed, but whose action status is deemed incomplete because the database had not been updated to reflect the action in time for this report.
9. Actionspending were excluded from the calculation.

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