Food and Drug Administration: FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs

PDF Version Also Available for Download.

Description

A letter report issued by the Government Accountability Office with an abstract that begins "Twenty years ago, GAO reported that the Food and Drug Administration (FDA) was concerned that it lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products--human drugs, biologics, and medical devices--marketed for sale in the United States. Since then, FDA, GAO, and others have raised concerns regarding FDA's ability to meet its oversight responsibilities. GAO was asked to review the resources supporting FDA's medical product oversight responsibilities. GAO examined trends in (1) FDA's funding and staffing resources for its ... continued below

Creation Information

United States. Government Accountability Office. June 19, 2009.

Context

This report is part of the collection entitled: Government Accountability Office Reports and was provided by UNT Libraries Government Documents Department to Digital Library, a digital repository hosted by the UNT Libraries. More information about this report can be viewed below.

Who

People and organizations associated with either the creation of this report or its content.

Provided By

UNT Libraries Government Documents Department

Serving as both a federal and a state depository library, the UNT Libraries Government Documents Department maintains millions of items in a variety of formats. The department is a member of the FDLP Content Partnerships Program and an Affiliated Archive of the National Archives.

Contact Us

What

Descriptive information to help identify this report. Follow the links below to find similar items on the Digital Library.

Description

A letter report issued by the Government Accountability Office with an abstract that begins "Twenty years ago, GAO reported that the Food and Drug Administration (FDA) was concerned that it lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products--human drugs, biologics, and medical devices--marketed for sale in the United States. Since then, FDA, GAO, and others have raised concerns regarding FDA's ability to meet its oversight responsibilities. GAO was asked to review the resources supporting FDA's medical product oversight responsibilities. GAO examined trends in (1) FDA's funding and staffing resources for its medical product oversight responsibilities from fiscal years 1999 through 2008, and (2) FDA's medical product oversight responsibilities during this same period. GAO analyzed FDA data on the agency's resources and workload, reviewed relevant federal laws, and interviewed FDA officials. GAO also examined more-detailed data on FDA's fiscal year 2004 through 2008 resources and workload in four key areas, representing a range of FDA's oversight responsibilities, both before and after a medical product is marketed in the United States."

Language

Item Type

Identifier

Unique identifying numbers for this report in the Digital Library or other systems.

Collections

This report is part of the following collection of related materials.

Government Accountability Office Reports

The U.S. Government Accountability Office (GAO) is an independent, nonpartisan agency that works for the U.S. Congress investigating how the federal government spends taxpayers' money. Its goal is to increase accountability and improve the performance of the federal government. The Government Accountability Office Reports Collection consists of over 13,000 documents on a variety of topics ranging from fiscal issues to international affairs.

What responsibilities do I have when using this report?

When

Dates and time periods associated with this report.

Creation Date

  • June 19, 2009

Added to The UNT Digital Library

  • June 12, 2014, 7:50 p.m.

Usage Statistics

When was this report last used?

Yesterday: 0
Past 30 days: 0
Total Uses: 5

Where

Geographical information about where this report originated or about its content.

Place Name

Publication Place

Map Information

  • map marker Automatically generated Place Name coordinates.
  • map marker Automatically generated Publication Place coordinates.
  • Repositioning map may be required for optimal printing.

Mapped Locations

Interact With This Report

Here are some suggestions for what to do next.

Start Reading

PDF Version Also Available for Download.

Citations, Rights, Re-Use

United States. Government Accountability Office. Food and Drug Administration: FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs, report, June 19, 2009; Washington D.C.. (digital.library.unt.edu/ark:/67531/metadc299278/: accessed September 24, 2017), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.