S. 1048: Enhanced Clinical Trial Design Act of 2017

115th Congress · introduced 2017-05-04 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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Follow this bill, step by step

Where it came from: introduced 2017-05-04 · official record
Who proposed it: Sen. Hatch, Orrin G. [R-UT] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Enhanced Clinical Trial Design Act of 2017

Plain summary

Enhanced Clinical Trial Design Act of 2017 This bill requires the Food and Drug Administration (FDA), in coordination with the National Institutes of Health, to convene a meeting to discuss clinical trial inclusion and exclusion criteria. The FDA must report on the meeting and issue guidance regarding eligibility criteria for clinical trials. The Government Accountability Office must report on individual access to investigational drugs for serious conditions through the FDA's expanded access program (i.e., compassionate use). The FDA must streamline review by institutional review boards of expanded access protocols for individual patients. The bill amends the Federal Food, Drug, and Cosmetic Act to require the manufacturer or distributor of an investigational drug for a serious condition that is designated a breakthrough therapy, fast track product, or regenerative advanced therapy to publish its expanded access policy not later than 15 days after the designation.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

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What does this mean? (plain words)

Official text

Enhanced Clinical Trial Design Act of 2017

Source: Congressional Research Service summary (Introduced in Senate)

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Hatch, Orrin G. [R-UT] · 3 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Michael F. Bennet (D-CO)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)

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Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in Senate)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-115s1048.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/115/s>

Record fed-us-cong115-s1048 · catalog fed-us-congress-bills-cong115 · updated 2026-11-15 by psicol fed-bills-cong115