LEADER 01515nam  2200397Ia 450 
001 9910698720503321
005 20090424152922.0
035   $a(CKB)5470000002396654
035   $a(OCoLC)319176343
035   $a(EXLCZ)995470000002396654
100   $a20090424d2008      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for FDA reviews and sponsors$b[electronic resource] $econtent and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS)
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,$d[2008]
215   $aii, 36 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on Apr. 24, 2009).
300   $a"April 2008".
320   $aIncludes bibliographical references (pages 27-29).
517   $aGuidance for FDA reviews and sponsors 
606   $aSomatic cells
606   $aCellular therapy$zUnited States
606   $aDrug approval$zUnited States
615  0$aSomatic cells.
615  0$aCellular therapy
615  0$aDrug approval
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910698720503321
996   $aGuidance for FDA reviews and sponsors$93492627
997   $aUNINA