For Industry

Standard Costs (in thousands of dollars) for Components of the Process for the Review of Animal Drug Applications

ADUFA III

Submission TypeAverage Standard Costs per Year ($ in thousands)
Drug ApplicationsFY 2014FY 2015FY 2016FY 2017FY 2018
INAD - Human Food Safety$2,066$2,159$2,272$2,329 
INAD - Safety & Efficacy - Food Animals$475$481$499$513 
INAD - Safety & Efficacy - Non Food Animals$909$906$927$962 
INAD - Environmental$82$83$83$82 
INAD - Manufacturing$246$235$219$210 
Administrative NADA$263$264$256$247 
Supplement - Safety & Efficacy$169$156$153$150 
Supplement - Other$17$18$18$18 

ADUFA II

Submission TypeAverage Standard Costs per Year ($ in thousands)
Drug ApplicationsFY 2009FY 2010FY 2011FY 2012FY 2013
INAD - Human Food Safety$1,447$1,548$1,802$1,922$1,979
INAD - Safety & Efficacy - Food Animals$417$440$458$451$469
INAD - Safety & Efficacy - Non Food Animals$912$976$989$966$943
INAD - Environmental$96$94$88$89$85
INAD - Manufacturing$248$264$252$249$252
Administrative NADA$286$286$280$269$269
Supplement - Safety & Efficacy$226$200$202$184$182
Supplement - Other$19$18$18$18$17

ADUFA I

Submission TypeAverage Standard Costs per Year ($ in thousands)
Drug ApplicationsFY 2004FY 2005FY 2006FY 2007FY 2008
INAD - Human Food Safety$1,291$1,013$1,248$1,496$1,283
INAD - Safety & Efficacy - Food Animals$1,056$949$722$515$380
INAD - Safety & Efficacy - Non Food Animals$542$938$1,029$850$882
INAD - Environmental$25$27$69$104$100
INAD - Manufacturing$249$214$210$176$213
Administrative NADA$85$171$231$215$265
Supplement - Safety & Efficacy$92$93$115$113$192
Supplement - Other$12$15$15$16$18

 

Page Last Updated: 09/13/2018
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