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S. 1634

BillFederalSenateIn Committee
FREED of Opioids Act
About This Bill
Committee
Latest Action · May 13, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Congress
117th (2021–2023)
Introduced
May 13, 2021
Cosponsors (1)
0D 1R
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Summary

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FDA Review of Efficacy of EERW Double-Blinds of Opioids Act or the FREED of Opioids Act This bill requires the Food and Drug Administration (FDA) to take certain actions to determine whether to permit the use of a certain methodology for drug clinical trials. Specifically, the FDA must seek to contract with the National Academy of Sciences (NAS) for the NAS to conduct a study on the effectiveness of using enriched enrollment randomized withdrawal methodology in demonstrating the efficacy of opioid drugs in treating chronic pain. The FDA must also convene a meeting of two specified FDA advisory committees to review the NAS study and vote on whether to permit the use of this methodology in drug clinical trials.

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