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- Title
Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union.
- Authors
Giezen, Thijs J.; Mantel-Teeuwisse, Aukje K.; Straus, Sabine M. J. M.; Schellekens, Huub; Leufkens, Hubert G. M.; Egberts, Antoine C. G.
- Abstract
The article presents a study designed to determine the nature, frequency and timing of regulatory actions created to ensure safety following the approval of biologicals. The study involved biologicals which were approved in the European Union or the United States between 1995 and 2007. Safety regulatory actions including written communications to health care professionals, black box warnings, and market withdrawals were collected. The encoding of safety information is discussed. A data analysis which includes hazard ratios is included. Researchers concluded that safety problems are often related to infections and recommend close monitoring since biologicals first approved in a class were more likely to be subject to regulatory action.
- Subjects
UNITED States; SAFETY regulations; BIOLOGICALS -- Law &; legislation; WARNINGS; DRUG approval; INFECTION; EUROPEAN Union
- Publication
JAMA: Journal of the American Medical Association, 2008, Vol 300, Issue 16, p1887
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.300.16.1887