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001 9910698724403321
005 20090423145856.0
035   $a(CKB)5470000002396614
035   $a(OCoLC)319065082
035   $a(EXLCZ)995470000002396614
100   $a20090423d2008      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $eproviding regulatory submissions in electronic format, postmarketing indivudal case safety reports
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :$cCenter for Biologics Evaluation and Research,$d[2008]
215   $a8 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on Apr. 23, 2009).
300   $a"Draft guidance".
300   $a"June 2008."
517   $aGuidance for industry 
606   $aDrug testing$zUnited States$vCase studies
606   $aElectronic filing systems$zUnited States
615  0$aDrug testing
615  0$aElectronic filing systems
712 02$aCenter for Drug Evaluation and Research (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
801  2$bGPO
906   $aBOOK
912   $a9910698724403321
996   $aGuidance for industry$93434577
997   $aUNINA