Sec. 2083. Finalizing draft guidance on expanded access

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Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human Services shall finalize the draft guidance entitled Expanded Access to Investigational Drugs for Treatment Use—Qs & As and dated May 2013. The final guidance referred to in subsection

(a)shall clearly define how the Secretary of Health and Human Services interprets and uses adverse drug event data reported by investigators in the case of data reported from use under a request submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb(b) ).

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U.S. Code

Expanded access to unapproved therapies and diagnostics
§ 360bbb

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Sec. 2083

Finalizing draft guidance on expanded access

U.S.C.§ 360bbb

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