LEADER 01466nam 2200385Ia 450 001 9910698929103321 005 20090716152724.0 035 $a(CKB)5470000002398587 035 $a(OCoLC)426052269 035 $a(EXLCZ)995470000002398587 100 $a20090716d2005 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry and FDA staff$b[electronic resource] $eapplication user fees for combination products 210 1$a[Rockville, MD] :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products,$d[2005] 215 $a15 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on July 17, 2009). 300 $a"April 2005". 517 $aGuidance for industry and FDA staff 606 $aUser charges$xGovernment policy$zUnited States 606 $aDrug approval$xGovernment policy$zUnited States 606 $aChemotherapy, Combination 615 0$aUser charges$xGovernment policy 615 0$aDrug approval$xGovernment policy 615 0$aChemotherapy, Combination. 712 02$aUnited States.$bFood and Drug Administration.$bOffice of Combination Products. 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698929103321 996 $aGuidance for industry and FDA staff$93451983 997 $aUNINA