S.1048 - Enhanced Clinical Trial Design Act of 2017115th Congress (2017-2018)
|Sponsor:||Sen. Hatch, Orrin G. [R-UT] (Introduced 05/04/2017)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||Senate - 05/04/2017 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions)|
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Summary: S.1048 — 115th Congress (2017-2018)All Information (Except Text)
Introduced in Senate (05/04/2017)
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.