BPCA adverse event reporting

Executive Summary

FDA will update the subcommittee on adverse event reporting for several products as mandated by the Best Pharmaceuticals for Children Act on June 12. AE reporting will be detailed for Pfizer's Zoloft (sertraline) and Alza's Ditropan (oxybutynin). An interim update will be presented on Pfizer's Lipitor (atorvastatin) and Merck's Zocor (simvastatin). The committee heard a preliminary presentation on Zoloft in March (1"The Pink Sheet" March 31, p. 9) The meeting will begin at 8:30 a.m. on June 11 at the Holiday Inn in Gaithersburg, Md. On June 12, the discussion on adverse event reporting will start at 3:15 p.m. after the committee meets in closed session...