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21 U.S.C. § 360bbb–8a

Optimizing global clinical trials

United States · Title 21 — FOOD AND DRUGS · Status: effective

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21 U.S.C. § 360bbb–8a, Optimizing global clinical trials, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454332
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Full text

The Secretary shall— enhance the commitment to provide consistent parallel scientific advice to manufacturers seeking simultaneous global development of new medical products in order to— In this section, the term “medical product” means a drug, as defined in subsection (g) of section 321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)]. Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter or under the Public Health Service Act [42 U.S.C. 201 et seq.].

Legislative history

The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.

  • Enacted byPub. L. 112-144(S. 3187)2012-07-09
    Food and Drug Administration Safety and Innovation Act
    House: no recorded tallySenate: 96–1
  • Amended byPub. L. 114-255(H.R. 34)2016-12-13
    21st Century Cures Act
    House: no recorded tallySenate: no recorded tally