Issue Date: March 14, 2016 | Web Date: March 11, 2016
FDA wants to end pediatric priority review program
FDA officials do not support continuing the pediatric voucher program, scheduled to expire on Oct. 1. Created in 2012, the program is meant to incentivize the development of drugs against rare pediatric diseases. A similar program targeting neglected tropical diseases dates back to 2007.
Awarded by FDA upon a drug’s approval, these vouchers can be used on another product to shorten regulatory review to six months—a 40% reduction. If the awardee doesn’t need the voucher, . . .
You Do Not Have Access to C&EN Protected Content.
- Chemical & Engineering News
- ISSN 0009-2347
- Copyright © American Chemical Society