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Rare Diseases: Too Early to Gauge Effeectiveness of FDAs Pediatric Voucher Program
Rare Diseases: Too Early to Gauge Effeectiveness of FDAäó»s Pediatric Voucher Program
Our Price: $20.00
By Marcia Crosse (au)
Year: 2016
Pages: 32
Binding Paperback
ISBN 978-1-4578-7262-4

Product Code: 1457872625

Almost 7,999 rare diseases, most of which are serious or life-threatening, affect more than 25 million Americans. About half of all rare diseases affect children, and few of these diseases have viable treatments. To encourage the development of drugs to treat or prevent rare pediatric diseases, the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 authorized FDA to award a priority review voucher to a drug sponsor upon approval of that sponsors drug to treat a rare pediatric disease. A drug sponsor can later redeem the voucher when submitting another new drug application to treat any disease or condition in adults or children, or sell or transfer the voucher to another sponsor. A voucher entitles a sponsor to a 6-month priority review by FDA rather than the 10-month standard review. This report examined what is known abut the effectiveness of the pediatric voucher program. Table and figure. This is a print on demand report.

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