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PEG-Intron/Ribavirin Pediatric Responder Studies Address Safety Concerns

Executive Summary

PEG-Intron/ribavirin combination studies in children with hepatitis C should consider enrolling only early responders to therapy to minimize adverse events, committee member Robert Fink, MD, Children's National Medical Center, suggested at an April 23 meeting of FDA's Anti-Infective Drugs Advisory Committee/Pediatric Subcommittee.

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