H.R. 1066 · 114th Congress
Clinical Trials Modernization Act of 2015
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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
CollinsSponsor2 cosponsors · 2 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to allow sponsors of applications for new drugs, biological products, and medical devices to propose incorporation of alternative statistical methods, including adaptive trial design and Bayesian methods, into clinical trial protocols and marketing…
What it does: CRS summary · Introduced in House · Feb 25, 2015
Clinical Trials Modernization Act of 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to allow sponsors of applications for new drugs, biological products, and medical devices to propose incorporation of alternative statistical methods, including adaptive trial design and Bayesian methods, into clinical trial protocols and marketing applications.
The FDA is required to issue guidance that establishes or clarifies standards for using alternative statistical methods in clinical trials.
The FDA must establish a process under which a post-approval study or clinical trial required by the FDA is periodically evaluated to determine whether the trial or study is no longer scientifically warranted or whether the design should be renegotiated because of changes in medical practice or the standard of care.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Clinical Trials Modernization Act of 2015
Latest action (Feb 27, 2015): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Feb 25, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.