H.R. 2438
Referred to CommitteeTo amend the Federal Food, Drug, and Cosmetic Act with respect to broader application of Bayesian statistics and adaptive trial designs.
Introduced 5/19/2015•114th Congress•House
Latest Action
Referred to the Subcommittee on Health.
5/22/2015 • House
Summary
This bill requires the Food and Drug Administration to issue guidance that addresses using alternative statistical methods, including adaptive trial design and Bayesian methods, in clinical trials and in the development and review of drugs and biological products.
Introduced in House • 5/19/2015
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Topics & Subjects
Policy Area: Health
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Medical research
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Bill Journey
Originated in the House
Introduced
May 19, 2015
Referred to the House Committee on Energy and Commerce.
Committee Review
Floor Debate
Passed Chamber
Other Chamber
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Enacted into Law
Text Versions (1)
Introduced in House5/19/2015