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Proposed FDA Rules on Painkillers in U.S. Rile Cancer Community.
- 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.
- Subjects :
- *ANALGESICS
*DRUG laws
*PSYCHIATRIC drug laws
*LAW
Subjects
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