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HR 2415 114th Congress House

To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program.

Introduced: May 19, 2015 See on congress.gov
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This bill died when the 114th Congress ended
It never became law before the 114th Congress (2015–2016) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 22, 2015
Referred to the Subcommittee on Health.
May 19, 2015
Referred to the House Committee on Energy and Commerce.
May 19, 2015
Introduced in House
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 Latest action May 22, 2015

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a streamlined data review program under which the holder of an approved application for a drug or biological product may submit a summary of clinical data to support approval of the drug for the treatment of cancer or another indication subject to the program.

For a drug to be eligible for the streamlined data review program there must be a database regarding the safety of the drug and the full data sets used to develop the data summaries must be submitted, unless the FDA determines that the full data sets are not required.

The FDA must annually publish: (1) the number of applications reviewed under the streamlined data review program, (2) the average time for completion of review under the streamlined data review program compared to review of other applications for new indications, and (3) the number of applications reviewed under the streamlined data review program for which the FDA made use of full data sets.
 Related & companion bills 1
  • HR 6 Related bill 21st Century Cures Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). H.R. 2415: To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program.. 114th Congress. Open America. https://openamerica.io/bill/114-HR-2415/
MLA
"H.R. 2415: To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program.." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-2415/.
Bluebook (legal)
H.R. 2415, 114th Cong. (2026), https://openamerica.io/bill/114-HR-2415/.
Markdown link
[H.R. 2415: To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program.](https://openamerica.io/bill/114-HR-2415/)
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