H.R. 2455 · 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine.
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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.
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PittsSponsorNo cosponsors.
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to define "precision drug or biological product." (Precision medications are commonly understood to be treatments for those patients who are likely to respond to the medication based on a biomarker, which is a biological characteristic such as a…
What it does: CRS summary · Introduced in House · May 19, 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to define "precision drug or biological product." (Precision medications are commonly understood to be treatments for those patients who are likely to respond to the medication based on a biomarker, which is a biological characteristic such as a genetic factor.)
The FDA must issue and periodically update guidance that addresses the development and use of biomarkers to identify the subset of patients that are likely to respond to a medication.
The FDA may rely upon data previously submitted for a different approved medication or indication to expedite the clinical development of a precision medication that has been designated for the treatment of a serious or rare condition.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine.
Latest action (May 22, 2015): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: May 19, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.