Sec. 505. Public meeting on clinical study flexibilities initiated in response to COVID–19 pandemic
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Not later than 180 days after the date on which the COVID–19 emergency period ends, the Secretary of Health and Human Services shall convene a public meeting to discuss the recommendations provided by the Food and Drug Administration during the COVID–19 emergency period to mitigate disruption of clinical studies, including recommendations detailed in the guidance entitled Conduct of Clinical Trials of Medical Products During the COVID–19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards , as updated on August 8, 2021, and by any subsequent updates to such guidance.
The Secretary of Health and Human Services shall invite to such meeting representatives from the pharmaceutical and medical device industries who sponsored clinical studies during the COVID–19 emergency period and organizations representing patients. Not later than 90 days after the date on which the public meeting under subsection
(a)is convened, the Secretary of Health and Human Services shall make available on the public website of the Food and Drug Administration a report on the topics discussed at such meeting. Such topics shall include discussion of— the actions drug sponsors took to utilize such recommendations and the frequency at which such recommendations were employed; the characteristics of the sponsors, studies, and patient populations impacted by such recommendations; a consideration of how recommendations intended to mitigate disruption of clinical studies during the COVID–19 emergency period, including any recommendations to consider decentralized clinical studies when appropriate, may have affected access to clinical studies for certain patient populations, especially unrepresented or underrepresented racial and ethnic minorities; and recommendations for incorporating certain clinical study disruption mitigation recommendations into current or additional guidance to improve clinical study access and enrollment of diverse patient populations. In this section, the term COVID–19 emergency period has the meaning given the term emergency period in section 1135(g)(1)(B) of the Social Security Act ( 42 U.S.C. 1320b–5(g)(1)(B) ).
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- 42 USC 1320b–5(g)(1)(B)
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Sec. 505
Public meeting on clinical study flexibilities initiated in response to COVID–19 pandemic
Cite42 USC 1320b–5(g)(1)(B)
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