LEADER 01499nam  2200409Ia 450 
001 9910698759103321
005 20090409140810.0
035   $a(CKB)5470000002396264
035   $a(OCoLC)318119921
035   $a(EXLCZ)995470000002396264
100   $a20090409d2008      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for indusry$b[electronic resource] $eintegrated summary of effectiveness
210  1$aSilver Spring, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ;$aRockville, MD :$cCenter for Biologics Evaluation and Research (CBER),$d[2008]
215   $a13 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on Apr. 9, 2009).
300   $a"Procedural."
300   $a"Draft guidance"--PDF cover.
300   $a"August 2008."
320   $aIncludes bibliographical references (page 13).
517   $aGuidance for indusry 
606   $aDrugs$xEffectiveness
606   $aBiologicals$xEffectiveness
615  0$aDrugs$xEffectiveness.
615  0$aBiologicals$xEffectiveness.
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   $a9910698759103321
996   $aGuidance for indusry$93467946
997   $aUNINA