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By Lori Clapper, Web Editor

FDA Takes Closer Look At Novartis Drug
According to an AP report` on Businessweek.com, federal regulators are trying to determine whether Novartis' Parkinson's disease drug Stalevo causes an increased risk of heart attacks or strokes. Clinical trial data has shown a slight increased risk, but it's not proven that Stalevo is to blame. Many patients taking the drug are already at high-risk for cardiovascular disease.

Drug Safety And Risk Management Advisory Committee To Meet
On September 14, the FDA's Drug Safety and Risk Management Advisory Committee will meet to discuss the abuse potential of dextromethorphan and the public health benefits and risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug products. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for dextromethorphan in response to the increased incidence of abuse, especially among adolescents.

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SNBL USA Receives Warning Letter
According to an FDA inspection, SNBL USA did not adhere to statutory requirements and FDA regulations that govern conduct within nonclinical laboratories. The FDA's warning letter to SNBL USA emphasizes several points, including personnel failing to understand their functions and the study director failing to ensure Good Laboratory Practice (GLP) regulations were followed.