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How to make it by sunset

Executive Summary

Companies must respond in writing to FDA pediatric written requests before the FDAMA pediatric exclusivity provision sunsets on Jan. 1, 2002, in order to qualify for six-month exclusivity, CDER Associate Director of Pediatrics Dianne Murphy, MD, informed a West Chester University pharmaceutical scholarship conference May 12. A bill to reauthorize exclusivity has been introduced in the Senate (1"The Pink Sheet" May 14, p. 21)
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