Research Catalog

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

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

Available Online

https://purl.fdlp.gov/GPO/LPS111001

Details

Additional 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.)
Description
18 pages : digital, PDF file
Alternative Title
New contrast imaging indication considerations for devices and approved drug and biological products
Subject
  • Contrast-enhanced magnetic resonance imaging > Equipment and supplies > Evaluation
  • Contrast-enhanced ultrasound > Equipment and supplies > Evaluation
  • Biomedical materials > Evaluation
Note
  • Title from PDF title page (viewed on Apr. 6, 2009).
  • "Draft guidance."
  • "September 2008."
System Details (note)
  • 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.
Call Number
GPO Internet HE 20.4002:C 74
OCLC
marcive317882445
Title
Guidance for industry : new contrast imaging indication considerations for devices and approved drug and biological products.
Publisher
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]
Type of Content
text
Type of Medium
computer
Type of Carrier
online resource
System 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.
Connect to:
https://purl.fdlp.gov/GPO/LPS111001
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.)
Gpo Item No.
0475 (online)
Sudoc No.
HE 20.4002:C 74 HE 20.4802:C 74
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