LEADER 01472nam  2200409Ia 450 
001 9910698953703321
005 20090702163343.0
035   $a(CKB)5470000002398338
035   $a(OCoLC)421145696
035   $a(EXLCZ)995470000002398338
100   $a20090702d2001      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $esubmitting marketing applications according to the ICH-CTD format, general considerations
210  1$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[2001]
215   $a13, 1, 2 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on July 2, 2009).
300   $a"Procedural".
300   $a"August 2001".
517   $aGuidance for industry 
606   $aDrug approval
606   $aDrugs$xMarketing
606   $aClinical trials$xReporting
615  0$aDrug approval.
615  0$aDrugs$xMarketing.
615  0$aClinical trials$xReporting.
712 02$aCenter for Drug Evaluation and Research (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910698953703321
996   $aGuidance for industry$93434577
997   $aUNINA