LEADER 01530oam  2200421Ia 450 
001 9910698826703321
005 20090528140048.0
035   $a(CKB)5470000002397601
035   $a(OCoLC)355507735
035   $a(EXLCZ)995470000002397601
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] $esubmitting type V drug master files to the Center for Biologics Evaluation and Research
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,$d[2001]
215   $ai, 5 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on May 28, 2009).
300   $a"Draft guidance".
300   $a"August 2001".
300   $aIncludes bibliographical references (p. 5).
517   $aGuidance for industry 
606   $aDrug factories$xGovernment policy$zUnited States
606   $aFiling systems$zUnited States
606   $aBiologicals$xGovernment policy$zUnited States
615  0$aDrug factories$xGovernment policy
615  0$aFiling systems
615  0$aBiologicals$xGovernment policy
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
801  2$bGPO
906   $aBOOK
912   $a9910698826703321
996   $aGuidance for industry$93434577
997   $aUNINA