The FDA Medical Device User Fee Program (open access)

The FDA Medical Device User Fee Program

None
Date: June 25, 2012
Creator: Johnson, Judith A.
System: The UNT Digital Library
FDA Regulation of Medical Devices (open access)

FDA Regulation of Medical Devices

This report provides a description of FDA's medical device review process divided into two parts: pre market requirements and post market requirements. Appendix A provides a brief history of laws governing medical device regulation and Appendix B provides a table of acronyms used in the report.
Date: June 25, 2012
Creator: Johnson, Judith A.
System: The UNT Digital Library
FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective (open access)

FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

The report describes why research on a drug's pharmacokinetics, safety, and effectiveness in children might be necessary. This report then presents why the marketplace has not provided sufficient incentives to manufacturers of drugs approved for adult use to study their effects in children. It also analyzes the impact of BPCA and PREA have had on pediatric drug research.
Date: June 25, 2012
Creator: Thaul, Susan
System: The UNT Digital Library
Haiti Under President Martelly: Current Conditions and Congressional Concerns (open access)

Haiti Under President Martelly: Current Conditions and Congressional Concerns

This report gives an overview of the current government in Haiti and status of recovery efforts following the 2010 earthquake. The Haitian government and the international donor community are implementing a 10-year recovery plan focusing on territorial, economic, social, and institutional rebuilding. The main priorities for U.S. policy regarding Haiti are to strengthen fragile democratic processes, continue to improve security, and promote economic development. Other concerns include the cost and effectiveness of U.S. aid; protecting human rights; combating narcotics, arms, and human trafficking; and alleviating poverty. Congressional concerns include the pace and effectiveness of reconstruction; respect for human rights, particularly for women; counternarcotics efforts; and security issues.
Date: June 25, 2012
Creator: Taft-Morales, Maureen
System: The UNT Digital Library
How FDA Approves Drugs and Regulates Their Safety and Effectiveness (open access)

How FDA Approves Drugs and Regulates Their Safety and Effectiveness

This report is a primer on drug approval and regulation: it describes how drugs are approved and come to the market, including FDA's role in that process and FDA and industry roles once drugs are on the pharmacy shelves.
Date: June 25, 2012
Creator: Thaul, Susan
System: The UNT Digital Library
Pension Benefit Guaranty Corporation (PBGC) and Defined Benefit Pension Plan Funding Issues (open access)

Pension Benefit Guaranty Corporation (PBGC) and Defined Benefit Pension Plan Funding Issues

None
Date: June 25, 2012
Creator: unknown
System: The UNT Digital Library
Transportation, Housing and Urban Development, and Related Agencies (THUD): FY2013 Appropriations (open access)

Transportation, Housing and Urban Development, and Related Agencies (THUD): FY2013 Appropriations

This report looks at Congress's FY2013 budget allocations for the Transportation, Housing and Urban Development, and Related Agencies (THUD) appropriations subcommittee.
Date: June 25, 2012
Creator: McCarty, Maggie & Peterman, David Randall
System: The UNT Digital Library
U.S. Foreign Aid to the Palestinians (open access)

U.S. Foreign Aid to the Palestinians

This report describes issues related to U.S. aid provided to Palestine to support prevention/combating against terrorism, creating coexistence with Israel and self-governance, and meeting humanitarian needs. In includes introductory and historical background as well as in-depth analysis of the types of U.S. bilateral aid to Palestine, U.S. contributions to the U.N. Relief and Works Agency for Palestine Refugees in the near East (UNRWA), and the issues involved in determining future aid.
Date: June 25, 2012
Creator: Zanotti, Jim
System: The UNT Digital Library