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

Bibliographic Details
Corporate Authors:	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.)
Format:	Government Document eBook
Language:	English
Published:	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]
Subjects:	Contrast-enhanced magnetic resonance imaging > Equipment and supplies > Evaluation. Contrast-enhanced ultrasound > Equipment and supplies > Evaluation. Biomedical materials > Evaluation.
Online Access:	https://purl.fdlp.gov/GPO/LPS111001

Description
Item Description:	Title from PDF title page (viewed on Apr. 6, 2009). "Draft guidance." "September 2008." Electronic resource.
Physical Description:	18 pages : digital, PDF file.
Format:	Mode of access: Internet at the FDA OCM web site. Address as of 4/06/09: http://www.fda.gov/oc/combination/contrastimg.pdf ; current access is available via PURL.