US Congress House Bill 2415 (Prior Session Legislation)

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Spectrum: Bipartisan Bill
Status: Introduced on May 19 2015 - 25% progression, died in committee
Action: 2015-05-22 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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

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

Rep. Michael Burgess [R-TX]

Rep. Eliot Engel [D-NY]

Date	Chamber	Action
2015-05-22	House	Referred to the Subcommittee on Health.
2015-05-19	House	Referred to the House Committee on Energy and Commerce.
2015-05-19	House	Introduced in House

HB6 (Related) 2015-07-13 - Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/house-bill/2415/all-info
Text	https://www.congress.gov/114/bills/hr2415/BILLS-114hr2415ih.pdf