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Title Guidance for industry [electronic resource] : new contrast imaging indication considerations for devices and approved drug and biological products.

Imprint 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]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4002:C 74    ---  Available
Description 18 p. : digital, PDF file
System Details Mode of access via the FDA OCM web site.
Note Title from PDF title page (viewed on Apr. 6, 2009).
"Draft guidance."
"September 2008."
Subject Contrast-enhanced magnetic resonance imaging -- Equipment and supplies -- Evaluation.
Contrast-enhanced ultrasound -- Equipment and supplies -- Evaluation.
Biomedical materials -- Evaluation.
Added Author United States. Food and Drug Administration. Office of Combination Products.
Center for Devices and Radiological Health (U.S.)
Center for Drug Evaluation and Research (U.S.)
Added Title New contrast imaging indication considerations for devices and approved drug and biological products
Gpo Item No. 0475 (online)
Sudoc No. HE 20.4002:C 74

 
    
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