Volume 94 Issue 11 | p. 13 | News of The Week
Issue Date: March 14, 2016 | Web Date: March 11, 2016

FDA wants to end pediatric priority review program

Benefits in advancing drugs for rare diseases is questioned
Department: Business
Keywords: pharmaceuticals, regulation, rare diseases

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, . . .

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