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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (1)

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

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.

Actions Overview (1)

Date Actions Overview
05/14/2015Introduced in House

All Actions (3)

Date All Actions
05/15/2015Referred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
05/14/2015Referred to the House Committee on Energy and Commerce.
Action By: House of Representatives
05/14/2015Introduced in House
Action By: House of Representatives

Cosponsors (0)

No cosponsors.

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
House Energy and Commerce05/14/2015 Referred to
House Energy and Commerce Subcommittee on Health05/15/2015 Referred to

A related bill may be a companion measure, an identical bill, a procedurally-related measure, or one with text similarities. Bill relationships are identified by the House, the Senate, or CRS, and refer only to same-congress measures.

Latest Summary (1)

There is one summary for H.R.2338. View summaries

Shown Here:
Introduced in House (05/14/2015)

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data may submit initial research concepts for feedback; (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries and analyses of data; and (3) patient experience data may be considered in the risk-benefit assessment of a new drug.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.