LEADER 01320nam 2200349Ia 450 001 9910698827303321 005 20090528120852.0 035 $a(CKB)5470000002397595 035 $a(OCoLC)355288915 035 $a(EXLCZ)995470000002397595 100 $a20090528d2001 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $einformation request and discipline review letters under the prescription drug user fee act 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research :$cCenter for Drug Evaluation and Research,$d[2001] 215 $a5 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on May 28, 2009). 300 $a"November 2001". 517 $aGuidance for industry 606 $aDrugs$xGovernment policy$zUnited States 615 0$aDrugs$xGovernment policy 712 02$aCenter for Biologics Evaluation and Research (U.S.) 712 02$aCenter for Drug Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698827303321 996 $aGuidance for industry$93434577 997 $aUNINA