LEADER 01443oam  2200385 a 450 
001 9910698720203321
005 20120501083250.0
035   $a(CKB)5470000002396657
035   $a(OCoLC)319178291
035   $a(EXLCZ)995470000002396657
100   $a20090424d2008      ua             0
101 0 $aeng
135   $aurbn|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for FDA reviews and sponsors $b[electronic resource] $econtent and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,$d[2008]
215   $a1 online resource (ii, 34 pages)
300   $aTitle from title screen (viewed on Apr. 24, 2009).
300   $a"April 2008".
320   $aIncludes bibliographical references (pages 32-34).
517   $aGuidance for FDA reviews and sponsors 
606   $aGene therapy
606   $aDrug approval$zUnited States
615  0$aGene therapy.
615  0$aDrug approval
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
801  2$bGPO
906   $aBOOK
912   $a9910698720203321
996   $aGuidance for FDA reviews and sponsors$93492627
997   $aUNINA