Join our mailing list!
(Your shopping cart is empty)
Diane Publishing Books
Rare Diseases: Too Early to Gauge Effeectiveness of FDAńˇ╗s Pediatric Voucher Program
Marcia Crosse (au)
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 sponsorńˇ╗s 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.
Guide to Homoeopathy
Dried Flower Arrangerĺs Bible
Bridges of Battle: Famous Battlefield Actions at Bridges & River Crossings
Whiz Kid of Wall Streetĺs Investment Guide: How I Returned 34% on My Portfolio, & You Can,Too
Yukon Alone: The Worldĺs Toughest Adventure Race
Share your knowledge of this product with other customers...
Be the first to write a review
Diane Publishing Co
PO Box 617
Darby, PA 19023-0617
Become an Affiliate
Send Us Feedback
Copyright ï¿½ 2004 Diane Publishing Company. All Rights Reserved.