Notes on the FY 2000 PDUFA Performance Report to Congress

1. Total approval time is the time from the initial submission of an original application to the issuance of an approval letter for that application. It includes both FDA's review time and the time the sponsor spends answering deficiencies noted by FDA, and can encompass several review "cycles." Not all applications receive approval letters.



2. United States General Accounting Office, Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities (GAO-02-958), September 2002.



3. Food and Drug Administration. CDER 2001 Report to the Nation: Improving Public Health Through Human Drugs. Rockville, Maryland, 2002 (p. 33). Available on the Internet at:
   • PDF - www.fda.gov/cder/reports/rtn/2001/rtn2001.pdf
   
   
   
   • HTML - www.fda.gov/cder/reports/rtn/2001/rtn2001.htm.

The PDUFA figure has changed from 2.7% to 2.5% with the approval of additional NMEs this year with no additional safety based withdrawals.


4. The count of FY 2002 submissions assumes that all submissions received in the last two months of FY 2002 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 redesignated as non-NMEs. In FY 2002, CDER designated 25 filings as NMEs initially (8 priority, 17 standard). Only 23 of these are 'discrete' (7 priority, 16 standard).



6. Includes those with late actions and those still pending whose goal date has passed and which have not had actions.



7. 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.



8. Actions pending and within goal were excluded from the calculation.

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