US Congress Senate Bill 1048 (Prior Session Legislation)

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Spectrum: Bipartisan Bill
Status: Introduced on May 4 2017 - 25% progression, died in committee
Action: 2017-05-04 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]

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.

Enhanced Clinical Trial Design Act of 2017

Sen. Orrin Hatch [R-UT]

Sen. Michael Bennet [D-CO]

Sen. Richard Burr [R-NC]

Sen. Robert Casey [D-PA]

Date	Chamber	Action
2017-05-04	Senate	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

SB934 (Related) 2017-05-11 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 76.
HB2430 (Related) 2017-08-18 - Became Public Law No: 115-52. (TXT | PDF)

Type	Source
Summary	https://www.congress.gov/bill/115th-congress/senate-bill/1048/all-info
Text	https://www.congress.gov/115/bills/s1048/BILLS-115s1048is.pdf