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100   $a20090406d2008      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $enew contrast imaging indication considerations for devices and approved drug and biological products
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in Office of Commissioner :$cCenter for Devices and Radiological Health (CDRH) :$cCenter for Drug Evaluation and Research (CDER),$d[2008]
215   $a18 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on Apr. 6, 2009).
300   $a"Draft guidance."
300   $a"September 2008."
517   $aGuidance for industry 
606   $aContrast-enhanced magnetic resonance imaging$xEquipment and supplies$xEvaluation
606   $aContrast-enhanced ultrasound$xEquipment and supplies$xEvaluation
606   $aBiomedical materials$xEvaluation
615  0$aContrast-enhanced magnetic resonance imaging$xEquipment and supplies$xEvaluation.
615  0$aContrast-enhanced ultrasound$xEquipment and supplies$xEvaluation.
615  0$aBiomedical materials$xEvaluation.
712 02$aUnited States.$bFood and Drug Administration.$bOffice of Combination Products.
712 02$aCenter for Devices and Radiological Health (U.S.)
712 02$aCenter for Drug Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
801  2$bGPO
906   $aBOOK
912   $a9910698772003321
996   $aGuidance for industry$93434577
997   $aUNINA