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Bill > HR2455


US HR2455

To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine.


summary

Introduced
05/19/2015
In Committee
05/22/2015
Crossed Over
Passed
Dead
01/03/2017

Introduced Session

114th Congress

Bill Summary

To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine. 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.

Committee Categories

Business and Industry, Health and Social Services

Sponsors (1)

Last Action

Referred to the Subcommittee on Health. (on 05/22/2015)

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