To amend the Federal Food, Drug, and Cosmetic Act to establish a process for externally led, science-focused drug development meetings, and for other purposes.
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 amend the Federal Food, Drug, and Cosmetic Act to establish a process for externally led, science-focused drug development meetings, and for other purposes., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Government Operations, Trade.
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 HCB67908A5DE446BD83F2797DD5827113: 1. Short title This Act may be cited as the Scientific External Process for Educated Review of Therapeutics Act of 2025 or the Scientific EXPERT Act of 2025.
- Section H08A5F8A786A6491CA1A784F3C8D1BEB4: 2. Science-focused drug development meetings The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by inserting after section 770 (21...
- Section H7CA0C65176954F97BDCEC8DF1D340D46: 770A. Science-focused drug development meetings The Secretary shall develop and implement a process for externally led, science-focused drug development...
- Section H5AF67528D3E948118C00F8B17711D58A: 770B. Required actions following EL–SFDD meetings In approving or licensing a drug under subsection (c) or (j) of section 505 of this Act or subsection (a) or...
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 amend the Federal Food, Drug, and Cosmetic Act to establish a process for externally led, science-focused drug development meetings, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Key Policy Areas
Healthcare, Government Operations, Trade
Primary Purpose
This bill, To amend the Federal Food, Drug, and Cosmetic Act to establish a process for externally led, science-focused drug development meetings, and for other purposes., 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
IntroducedMs. Matsui (for herself and Mr. Bilirakis) 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_secretary"
- → The Secretary identified in the operative section
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