Standard Costs for Components of the Process for the Review of Human Drug Applications

Estimates Made Pursuant to Section 736(d)(2)of the Federal Food, Drug, and Cosmetic Act
	All determined on the basis of the Arthur Andersen model developed in 1993								KPMG Model		From Time Rpt.
Submission Type	FY 93	FY 94	FY 95	FY 96	FY 97	FY 98	FY 99	FY 00	FY 01	FY 02	FY 03	FY 04	FY 05	FY 06
Drug Applications
IND	$70	$79	$98	$97	$84	$94	$105	$119	$200	$212	$299	$203	$240	$250
NDA with Clinical Data - NME	$887	$1,004	$1,243	$1,233	$1,065	$1,194	$1,328	$1,503	$1,920	$2,037	$2,116	$1,987	$2,456	$2,986
NDA with Clinical Data - Non-NME	$298	$337	$417	$414	$358	$401	$446	$505	$929	$986	$746	$760	$685	$777
NDA without Clinical Data	$127	$144	$178	$177	$152	$171	$190	$215	$261	$277	$561	$411	$476	$481
Supplement with Clinical Data	$151	$171	$212	$210	$181	$203	$226	$256	$111	$118	$175	$142	$255	$224
Supplement without Clinical Data	$6	$7	$8	$8	$7	$8	$9	$10	$8	$8	$18	$17	$17	$23
Biologic Applications
IND	$184	$230	$234	$266	$204	$173	$243	$175	$287	$279	$361	$400	$437	$394
BLA						$1,118	$1,568	$1,128	$2,788	$2,708	$4,394	$4,075	$4,492	$2,626
PLA	$1,078	$1,345	$1,369	$1,560	$1,194	$1,016	$1,426	$1,026
ELA	$177	$221	$225	$256	$196	$167	$234	$168
Supplement with Clinical Data	$561	$700	$713	$812	$622	$529	$742	$534	$195	$190	$228	$367	$239	$265
Supplement without Clinical Data	$34	$42	$43	$49	$38	$32	$45	$32	$31	$30	$21	$41	$42	$40

¹ Standard costs include all costs associated with application review, including rent, overhead, and centrally funded costs. Method revised in FY 2001-2002 based on KPMG study, and in 2003 on time reporting data. Time reporting method revised with better allocation of indirect cost beginning in 2004.

Last Updated: February 4, 2008

Standard Costs for Components of the Process for the Review of Human Drug Applications 1 ($000)

Standard Costs for Components of the Process for the
Review of Human Drug Applications ¹ ($000)