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FDA restructuring

This article was originally published in The Tan Sheet

Executive Summary

Office of Pediatric Drug Development & Special Initiatives, forming Oct. 1, will be headed by ODE IV Director Dianne Murphy, MD. Division of Special Pathogenic & Immunologic Drug Products Director Mark Goldberger, MD, will take over as ODE IV acting director. The office will assist with pediatric drug policy and regulatory support, handle "initiatives related to the study and labeling of drugs in pregnancy" and serve as a liaison with external pediatric advocacy groups, CDER says. Originally slated to be the Office of Pediatric Therapeutics, the office reflects the upsurge in pediatric clinical trials following passage of FDAMA's pediatric exclusivity provisions (1"The Tan Sheet" July 16, p. 16)

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