Skip to main content
S 1048 115th Congress Senate Health Administrative law and regulatory procedures Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Government studies and investigations Medical research Public participation and lobbying

Enhanced Clinical Trial Design Act of 2017

Introduced: May 4, 2017 See on congress.gov
Sign in to write a letter Sign in to watch
This bill died when the 115th Congress ended
It never became law before the 115th Congress (2017–2018) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 4, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 4, 2017
Introduced in Senate
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Plain-English summary Congressional Research Service

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.
What's happening now May 4, 2017

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Related & companion bills 2
  • S 934 Related bill FDA Reauthorization Act of 2017
  • HR 2430 Related bill FDA Reauthorization Act of 2017
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 1
All 1 Democratic 1
D
Bennet, Michael F.
Colorado · May 4, 2017
Cite this page click to expand
APA
U.S. Congress. (2026). S. 1048: Enhanced Clinical Trial Design Act of 2017. 115th Congress. Open America. https://openamerica.io/bill/115-S-1048/
MLA
"S. 1048: Enhanced Clinical Trial Design Act of 2017." 115th Congress, 2026, Open America, https://openamerica.io/bill/115-S-1048/.
Bluebook (legal)
S. 1048, 115th Cong. (2026), https://openamerica.io/bill/115-S-1048/.
Markdown link
[S. 1048: Enhanced Clinical Trial Design Act of 2017](https://openamerica.io/bill/115-S-1048/)
Report a problem