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008 090406s2008 mdu o f000 0 eng d;

040 a| GPOc| GPOd| GPOd| MvI;

049 a| ERE#;

074 a| 0475 (online)z| 0499-T-02 (online);

086 0 a| HE 20.4002:C 74z| HE 20.4802:C 74;

245 00 a| Guidance for industry :b| new contrast imaging indication considerations for devices and approved drug and biological products.;

246 30 a| New contrast imaging indication considerations for devices and approved drug and biological products;

260 a| Rockville, MD :b| U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in Office of Commissioner :b| Center for Devices and Radiological Health (CDRH) :b| Center for Drug Evaluation and Research (CDER),c| [2008];

300 a| 18 p. :b| digital, PDF file;

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

538 a| Mode of access: Internet at the FDA CBER web site. Address as of 4/06/09: http://www.fda.gov/oc/combination/contrastimg.pdf ; current access is available via PURL.;

500 a| Title from PDF title page (viewed on Apr. 6, 2009).;

500 a| "Draft guidance.";

500 a| "September 2008.";

500 a| GPO Cataloging Record Distribution Program (CRDP).;

650 0 a| Contrast-enhanced magnetic resonance imagingx| Equipment and suppliesx| Evaluation.=| ^A1000421;

650 0 a| Contrast-enhanced ultrasoundx| Equipment and suppliesx| Evaluation.=| ^A1000416;

650 0 a| Biomedical materialsx| Evaluation.=| ^A520;

710 1 a| United States.b| Food and Drug Administration.b| Office of Combination Products.=| ^A717027;

710 2 a| Center for Devices and Radiological Health (U.S.)=| ^A119573;

710 2 a| Center for Drug Evaluation and Research (U.S.)=| ^A431016;

856 40 u| https://purl.fdlp.gov/GPO/LPS111001;

949 a| Click on web addressw| asish| joyner94;

596 a| 1;

998 a| 1897544;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 1897544-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 9/11/2009x| EDOCUMENTz| JERESOURCEo| .STAFF. jlhb;

Guidance for industry : new contrast imaging indication considerations for devices and approved drug and biological products.

Other author	United States. Food and Drug Administration. Office of Combination Products.
Other author	Center for Devices and Radiological Health (U.S.)
Other author	Center for Drug Evaluation and Research (U.S.)
Format	Electronic
Publication Info	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in Office of Commissioner : Center for Devices and Radiological Health (CDRH) : Center for Drug Evaluation and Research (CDER), [2008]
Description	18 p. : digital, PDF file
Supplemental Content	https://purl.fdlp.gov/GPO/LPS111001
Subjects	Contrast-enhanced magnetic resonance imaging--Equipment and supplies. --Evaluation. Contrast-enhanced ultrasound--Equipment and supplies. --Evaluation. Biomedical materials--Evaluation.

Portion of title	New contrast imaging indication considerations for devices and approved drug and biological products
General note	Title from PDF title page (viewed on Apr. 6, 2009).
General note	"Draft guidance."
General note	"September 2008."
General note	GPO Cataloging Record Distribution Program (CRDP).
Technical details	Mode of access: Internet at the FDA CBER web site. Address as of 4/06/09: http://www.fda.gov/oc/combination/contrastimg.pdf ; current access is available via PURL.
GPO item number	0475 (online) 0499-T-02 (online)
Govt. docs number	HE 20.4002:C 74 HE 20.4802:C 74

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Guidance for industry : new contrast imaging indication considerations for devices and approved drug and biological products.

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