Bill
Bill > HR2338
US HR2338
To amend the Federal Food, Drug, and Cosmetic Act to provide for the development and use of patient experience data to enhance the structured risk-benefit assessment framework, and for other purposes.
summary
Introduced
05/14/2015
05/14/2015
In Committee
05/15/2015
05/15/2015
Crossed Over
Passed
Dead
01/03/2017
01/03/2017
Introduced Session
114th Congress
Bill Summary
To amend the Federal Food, Drug, and Cosmetic Act to provide for the development and use of patient experience data to enhance the structured risk-benefit assessment framework, and for other purposes. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish processes under which: (1) an entity seeking to develop patient experience data may submit initial research concepts for feedback; (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries and analyses of data; and (3) patient experience data may be considered in the risk-benefit assessment of a new drug. "Patient experience data" is data collected by patients or others that is intended to facilitate the FDA's risk-benefit assessments, including information about the impact of a disease or a therapy on patients' lives. The FDA must convene workshops and publish guidance on the patient experience data processes described above.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (1)
Last Action
Referred to the Subcommittee on Health. (on 05/15/2015)
Official Document
bill text
bill summary
Loading...
bill summary
Loading...
bill summary
Loading...