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S. 1634

FREED of Opioids Act

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.

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sen. Manchin, Joe, III [D-WV](D-WV)Sponsor
1 cosponsor1 R
1cosponsors1committees2actions8subjects
  1. IntroReferral

    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Health, Education, Labor, and Pensions Committee
  2. IntroReferral10000

    Introduced in Senate

FREED of Opioids Act — Informed