Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric diseases

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Section 529(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360ff(b) ) is amended by striking paragraph

(5)and inserting the following: The Secretary may not award any priority review vouchers under paragraph

(1)after September 30, 2020, unless the rare pediatric disease product application— is for a drug that, not later than September 30, 2020, is designated under subsection

(d)as a drug for a rare pediatric disease; and is, not later than September 30, 2022, approved under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act. . The Advancing Hope Act of 2016 ( Public Law 114–229 ) is amended by striking section 3.

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U.S. Code

Priority review to encourage treatments for rare pediatric diseases
§ 360ff

public-private-law

Advancing Hope Act of 2016
Public Law 114-229

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Sec. 3013

Reauthorization of program to encourage treatments for rare pediatric diseases

U.S.C.§ 360ff

Pub. L.Public Law 114-229

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