Bill
Bill > HR2415
US HR2415
US HR2415To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program.
summary
Introduced
05/19/2015
05/19/2015
In Committee
05/22/2015
05/22/2015
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 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.
AI Summary
This bill, aiming to amend the Federal Food, Drug, and Cosmetic Act, establishes a streamlined data review program for drugs and biological products, particularly those used to treat cancer or other specified indications. Under this program, companies holding an approved application for a drug can submit a "qualified data summary," which is a summary of clinical data demonstrating safety and effectiveness for a new use, instead of the full data sets, provided there's an existing safety database and the Food and Drug Administration (FDA) agrees full data sets aren't necessary. The FDA is required to annually publish data on how many applications are reviewed under this program, the average review times compared to other applications for new uses, and how often full data sets were used. This initiative is intended to expedite the approval process for certain drug applications by allowing the FDA to make decisions based on these summarized data.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (2)
Last Action
Referred to the Subcommittee on Health. (on 05/22/2015)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location | Created |
|---|---|---|
| State Bill Page | https://www.congress.gov/bill/114th-congress/house-bill/2415/all-info | 05/20/2015 |
| BillText | https://www.congress.gov/114/bills/hr2415/BILLS-114hr2415ih.pdf | 07/06/2016 |
| Bill | https://www.congress.gov/114/bills/hr2415/BILLS-114hr2415ih.pdf.pdf | 07/06/2016 |
| BillText | http://gpo.gov/fdsys/pkg/BILLS-114hr2415ih/pdf/BILLS-114hr2415ih.pdf | 05/28/2015 |
| Bill | http://gpo.gov/fdsys/pkg/BILLS-114hr2415ih/pdf/BILLS-114hr2415ih.pdf.pdf | 05/28/2015 |
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