Sec. 3. Evaluations of required postapproval studies and clinical trials
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Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3) ) is amended by adding at the end the following new subparagraph: The Secretary shall establish a process under which the Secretary, on the initiative of the Secretary or at the request of a responsible person, shall periodically evaluate a postapproval study or clinical trial required to be conducted under this paragraph to determine whether— the trial or study is no longer scientifically warranted; or the design, or the timelines applicable to the completion of, the study or trial should be renegotiated because of changes in medical practice or the standard of care.
In the case of a determination under clause (i)(I) that a postapproval study or clinical trial required to be conducted under this paragraph is no longer scientifically warranted, the Secretary shall no longer require the responsible person to conduct the study or trial. In the case of a determination under clause (i)(II) that the design, or the timelines applicable to the completion of, a postapproval study or clinical trial required to be conducted under this paragraph should be renegotiated, the Secretary shall enter into negotiations with the responsible person to make such changes as may be necessary to such design or timelines as the Secretary determines are necessary. .
Not later than one year after the date of the enactment of this Act, the Secretary shall issue draft guidance on the implementation of subparagraph
(G)of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3) ), as added by subsection (a). Not later than two years after such date of enactment, the Secretary shall issue final guidance on such implementation.
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Sec. 3
Evaluations of required postapproval studies and clinical trials
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