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035   $a(EXLCZ)995470000002397763
100   $a20090603d2006      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $epatient-reported outcome measures, use in medical product development to support labeling claims
210  1$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 :$cCenter for Devices and Radiological Health,$d[2006]
215   $aii, 32 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on June 3, 2009).
300   $a"Draft guidance".
300   $a"Clinical/medical".
300   $a"February 2006".
517   $aGuidance for industry 
606   $aOutcome assessment (Medical care)$zUnited States
606   $aMedical instruments and apparatus$xLabeling$xGovernment policy$zUnited States
606   $aDrugs$xLabeling$xGovernment policy$zUnited States
615  0$aOutcome assessment (Medical care)
615  0$aMedical instruments and apparatus$xLabeling$xGovernment policy
615  0$aDrugs$xLabeling$xGovernment policy
712 02$aCenter for Drug Evaluation and Research (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
712 02$aCenter for Devices and Radiological Health (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910698810703321
996   $aGuidance for industry$93434577
997   $aUNINA