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.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
This 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., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Government Operations, Agriculture.
Who Benefits and How
health care providers and patients may benefit from new authority, funding, eligibility, regulatory clarity, or reduced risk created by the bill.
Who Bears the Burden and How
federal implementing agencies, health care providers and patients may take on implementation duties, reporting obligations, compliance costs, or oversight responsibilities.
Key Provisions
- Section S1: 1. Short title This Act may be cited as the FDA Review of Efficacy of EERW Double-Blinds of Opioids Act or the FREED of Opioids Act.
- Section id017C48E847184027BCB216A3720F877C: 2. Consideration of enriched enrollment randomized withdrawal methodology Not later than 2 years after the date of enactment of this Act, the Secretary of...
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
This 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., changes federal law or congressional policy affecting health care providers and patients.
Key Policy Areas
Healthcare, Government Operations, Agriculture
Primary Purpose
This 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., changes federal law or congressional policy affecting health care providers and patients.
Policy Domains
Whole bill
Identified Gains
- health care providers and patients
Identified Costs
- federal implementing agencies
- health care providers and patients
Sponsors
Legislative Progress
IntroducedMr. Manchin (for himself and Mr. Braun) introduced the following …
Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_commission"
- → The commission identified in the operative section
- "secretary_of_health_and_human_services"
- → Secretary of Health and Human Services
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology