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Proposed FDA Rules on Painkillers in U.S. Rile Cancer Community.

Authors :
Brower, Vicki
Source :
JNCI: Journal of the National Cancer Institute. 10/21/2009, Vol. 101 Issue 20, p1376-1377. 2p.
Publication Year :
2009

Abstract

The article discusses the proposed rules of Food and Drug Administration (FDA) on painkillers in the U.S. It is inferred that the new mandate is based on the FDA Amendments of 2007 which requires companies to secure a Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits of an agent and to respond to an inreasing rates of prescription opioid diversion, abuse and overdose. It is stated that approval is required on certain drugs such as opioids contaning morphine, fentanyl and oxycodone otherwise the drug may be pulled out from the market.

Details

Language :
English
ISSN :
00278874
Volume :
101
Issue :
20
Database :
Academic Search Index
Journal :
JNCI: Journal of the National Cancer Institute
Publication Type :
Academic Journal
Accession number :
45250593
Full Text :
https://doi.org/10.1093/jnci/djp365