Bill

Bill > HR2415


US HR2415

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


summary

Introduced
05/19/2015
In Committee
05/22/2015
Crossed Over
Passed
Dead
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.

Committee Categories

Business and Industry, Health and Social Services

Sponsors (2)

Last Action

Referred to the Subcommittee on Health. (on 05/22/2015)

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