For Industry

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

Revised to Incorporate FY 2007 Standard Costs

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	FY 07
Drug Applications
IND	$70	$79	$98	$97	$84	$94	$105	$119	$200	$212	$299	$203	$240	$250	$285
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	$2,251
NDA with Clinical Data - Non-NME	$298	$337	$417	$414	$358	$401	$446	$505	$929	$986	$746	$760	$685	$777	$805
NDA without Clinical Data	$127	$144	$178	$177	$152	$171	$190	$215	$261	$277	$561	$411	$476	$481	$240
Supplement with Clinical Data	$151	$171	$212	$210	$181	$203	$226	$256	$111	$118	$175	$142	$255	$224	$248
Supplement without Clinical Data	$6	$7	$8	$8	$7	$8	$9	$10	$8	$8	$18	$17	$17	$23	$19
Biologic Applications
IND	$184	$230	$234	$266	$204	$173	$243	$175	$287	$279	$361	$400	$437	$394	$427
BLA						$1,118	$1,568	$1,128	$2,788	$2,708	$4,394	$4,075	$4,492	$2,626	$3,142
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	$627
Supplement without Clinical Data	$34	$42	$43	$49	$38	$32	$45	$32	$31	$30	$21	$41	$42	$40	$53

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.

For Industry

Section Contents Menu

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