ARTICLE | Politics & Policy

FDA issues draft guidance on pediatric Priority Review vouchers

November 18, 2014 3:24 AM UTC

FDA is seeking comments on its draft guidance entitled "Rare Pediatric Disease Priority Review Voucher," which outlines procedures for obtaining and using Priority Review vouchers issued for rare pediatric diseases. Comments are due Jan. 16, 2015.

The draft defines a rare pediatric disease as having a prevalence of <200,000 in the U.S. and >50% of patients aged under 18 years. ...