Sec. 502. Evaluation of the need for FDA authority to mandate postapproval studies or postmarket surveillance due to insufficient demographic subgroup data
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/bill/117/hr/7667/eh/section-502·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Not later than 2 years after the date of publication of final guidance pursuant to section 524B(b)(2) of the Federal Food, Drug, and Cosmetic Act, as added by section 501(c) of this Act, the Secretary of Health and Human Services shall commence an evaluation to assess whether additions or changes to statutes or regulations are warranted to ensure that sponsors conduct post-approval studies or postmarket surveillance where— premarket studies collected insufficient data for underrepresented subgroups according to the goals specified in the diversity action plans of such sponsors; and the Secretary has requested additional studies be conducted.
Not later than 180 days after the commencement of the evaluation under subsection (a), the Secretary of Health and Human Services shall submit a report to the Congress on the outcome of such evaluation, including any recommendations related to additional needed authorities.