Evolution and current status of United States Food and Drug Administration and European Medicines Agency regulatory guidance for studies of nosocomial pneumonia

2018 ◽  
Vol 24 (5) ◽  
pp. 379-384 ◽  
Author(s):  
George H. Talbot
Keyword(s):  
United States ◽  
Drug Administration ◽  
Nosocomial Pneumonia ◽  
Food And Drug Administration ◽  
Current Status ◽  
European Medicines Agency ◽  
Regulatory Guidance ◽  
United States Food ◽  
States Food

Nephrogenic systemic fibrosis

2013 ◽  
pp. 1001-1006
Author(s):  
Cate H. Orteu
Keyword(s):  
United States ◽  
Renal Failure ◽  
Contrast Agents ◽  
Drug Administration ◽  
Nephrogenic Systemic Fibrosis ◽  
Food And Drug Administration ◽  
The United States ◽  
European Medicines Agency ◽  
United States Food ◽  
States Food

Nephrogenic systemic fibrosis (NSF) is a severe and disabling fibrosing condition of the skin and systemic organs. It occurs in patients with renal failure who have been exposed to gadolinum-based contrast agents (GBCAs). The development of NSF should be preventable if adequate precautions are taken in relation to GBCA exposure in susceptible patients. New cases should be reported to the European Medicines Agency and/or the United States Food and Drug Administration.

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