Bill
Bill > S2737
US S2737
FREED of Opioids Act FDA Review of Efficacy of EERW Double-Blinds of Opioids Act
summary
Introduced
09/07/2023
09/07/2023
In Committee
09/07/2023
09/07/2023
Crossed Over
Passed
Dead
01/03/2025
01/03/2025
Introduced Session
118th Congress
Bill Summary
A bill to require the Food and Drug Administration to determine whether to permit the use of enriched enrollment randomized withdrawal methodology with respect to clinical trials.
AI Summary
This bill, the FREED of Opioids Act or FDA Review of Efficacy of EERW Double-Blinds of Opioids Act, requires the Food and Drug Administration (FDA) to convene meetings of two of its advisory committees to vote on whether to permit the use of the enriched enrollment randomized withdrawal (EERW) methodology in clinical trials of drugs, including opioid drugs. The bill also requires the FDA to conduct a study through the National Academy of Sciences on the effectiveness of EERW in demonstrating the efficacy of opioid drugs in treating chronic pain, and to review the approved labeling on all opioid drugs approved using EERW to determine whether the indications are supported by that 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 09/07/2023)
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/118th-congress/senate-bill/2737/all-info |
| BillText | https://www.congress.gov/118/bills/s2737/BILLS-118s2737is.pdf |
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