The FDA advisory group receives information on current methods for detecting contaminants in agency-regulated products and plans to discuss a subcommittee's review of bisphenol A use in food contact applications at an upcoming meeting. Although FDA has determined that BPA lining food containers is safe, a September study in the Journal of American Medical Association found higher concentrations of the substance in human urine is associated with cardiovascular disease, diabetes and liver-enzyme abnormalities (1"The Tan Sheet" Sept. 22, 2008, In Brief). In an Oct. 9 Federal Register notice, FDA says the board also will discuss its 2009 agenda topics during the meeting scheduled for Oct. 31 at the Washington, DC North/Gaithersburg Hilton in Gaithersburg, Md. The agency says background material on the topics should be available at least two days before the meeting

Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.

Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.