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
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
Plain-English 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.
What's happening now
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committees of jurisdiction
1
Cosponsors
1