Sec. 312. Increasing pharmaceutical options to treat an unmet medical need
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Subsection
(b)of section 506 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 ) is amended by adding at the end the following: For purposes of paragraph (1), a drug shall be deemed to address an unmet medical need for a disease or condition if fewer than 3 available drugs exist for the treatment of such disease or condition. .
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Sec. 312
Increasing pharmaceutical options to treat an unmet medical need
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