Bill

Bill > S1634


US S1634

US S1634
FREED of Opioids Act FDA Review of Efficacy of EERW Double-Blinds of Opioids Act


summary

Introduced
05/13/2021
In Committee
05/13/2021
Crossed Over
Passed
Dead
01/03/2023

Introduced Session

117th Congress

Bill Summary

A BILL To require the Food and Drug Administration to determine whether to permit the use of enriched enrollment ran- domized withdrawal methodology with respect to clinical trials.

AI Summary

This bill, the "FREED of Opioids Act FDA Review of Efficacy of EERW Double-Blinds of Opioids Act," requires the Food and Drug Administration (FDA) to convene a meeting of its advisory committees within 2 years to vote on whether to permit the use of the enriched enrollment randomized withdrawal (EERW) methodology in clinical trials of drugs, including opioids. The bill also requires the FDA to commission a study by the National Academy of Sciences on the effectiveness of EERW in demonstrating the efficacy of opioid drugs in treating chronic pain, and to consider the findings of that study in its review of the EERW methodology.

Committee Categories

Health and Social Services

Sponsors (2)

Last Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 05/13/2021)

bill text


bill summary

Loading...

bill summary

Loading...
Loading...