Bill
Bill > S1634
summary
Introduced
05/13/2021
05/13/2021
In Committee
05/13/2021
05/13/2021
Crossed Over
Passed
Dead
01/03/2023
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)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/117th-congress/senate-bill/1634/all-info |
| BillText | https://www.congress.gov/117/bills/s1634/BILLS-117s1634is.pdf |
| Bill | https://www.congress.gov/117/bills/s1634/BILLS-117s1634is.pdf.pdf |
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