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 Collection: Congressional Research Service Reports
U.S. and International Responses to the Global Spread of Avian Flu: Issues for Congress

U.S. and International Responses to the Global Spread of Avian Flu: Issues for Congress

Date: February 6, 2006
Creator: Salaam-Blyther, Tiaji & Chanlett-Avery, Emma
Description: This report will provide an account of global H5N1-related human infections and deaths, outline U.S. government and international responses to the global spread of H5N1, discuss situations in various countries affected by H5N1, and present some foreign policy issues for Congress.
Contributing Partner: UNT Libraries Government Documents Department
The Global Fund to Fight AIDS, Tuberculosis, and Malaria: Issues for Congress and U.S. Contributions from FY2001 to FY2013

The Global Fund to Fight AIDS, Tuberculosis, and Malaria: Issues for Congress and U.S. Contributions from FY2001 to FY2013

Date: May 15, 2012
Creator: Salaam-Blyther, Tiaji & Kendall, Alexandra E.
Description: The Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund, or the Fund) was established in 2002 as a public-private partnership that could provide significant financial support for global responses to HIV/AIDS, tuberculosis (TB), and malaria. In November 2011, the Global Fund Board announced that due to inadequate resources from donors, it would cancel its 11th round of funding, but would maintain support for existing activities to avoid disruptions in ongoing services. Global health advocates urge Congress to meet the President's FY2013 request for the Fund in order to support the sustainability of its activities and to encourage continued contributions from other donors. Although Congress has traditionally been a strong supporter of the Fund, several issues may affect congressional views about the Fund in the future, which are discussed in this report.
Contributing Partner: UNT Libraries Government Documents Department
Genetic Exceptionalism: Genetic Information and Public Policy

Genetic Exceptionalism: Genetic Information and Public Policy

Date: February 14, 2008
Creator: Sarata, Amanda K.
Description: This report provides an overview of the nature of genetic information and its implications for individuals, family, and society. Individuals utilize genetic information to guide health care and other decisions, when possible, and may experience anxiety as a result of genetic test results. Genetic test results for an individual may often be informative for other close family members and thus influence their care decisions. Society must grapple with the effect genetic information may have on our conception of disease, as well as its impact on issues like privacy and equity. The report ends by summarizing the main policy issues involved with a genetic exceptionalist approach to public policy, including defining genetic information; physically separating genetic information from other medical information; unintended disparities between “genetic” and “nongenetic” disease; and the effect of legislation on participation in genetic research, on uptake of genetic technology and on the delivery of high quality health care.
Contributing Partner: UNT Libraries Government Documents Department
Mental Health Parity and the Patient Protection and Affordable Care Act of 2010

Mental Health Parity and the Patient Protection and Affordable Care Act of 2010

Date: December 28, 2011
Creator: Sarata, Amanda K.
Description: This report provides a brief background on mental health parity and the policy discussion around parity in health insurance coverage; an overview of federal mental health parity law prior to the enactment of the ACA; and an analysis of the impact of the ACA.
Contributing Partner: UNT Libraries Government Documents Department
Mental Health Parity and the Patient Protection and Affordable Care Act of 2010

Mental Health Parity and the Patient Protection and Affordable Care Act of 2010

Date: January 7, 2011
Creator: Sarata, Amanda K.
Description: This report provides a brief background on mental health parity and the policy discussion around parity in health insurance coverage; an overview of federal mental health parity law prior to the enactment of the ACA; and an analysis of the impact of the ACA.
Contributing Partner: UNT Libraries Government Documents Department
Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

Date: March 27, 2014
Creator: Sarata, Amanda K.
Description: In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or tissue, to provide information in making health care decisions. Examples of IVDs include pregnancy test kits or blood glucose tests for home use; laboratory tests for infectious disease, such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and tests for various genetic diseases or conditions. More recently, a specific type of diagnostic test--called a companion diagnostic--has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine. This report provides an overview of federal regulation of IVDs by FDA, through the Federal Food, Drug, and Cosmetics Act (FFDCA) and the Public Health Service Act (PHSA), and by CMS, through the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
Contributing Partner: UNT Libraries Government Documents Department
Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

Date: December 17, 2014
Creator: Sarata, Amanda K. & Johnson, Judith A.
Description: In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or tissue, to provide information in making health care decisions. Examples of IVDs include pregnancy test kits or blood glucose tests for home use; laboratory tests for infectious disease, such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and tests for various genetic diseases or conditions. More recently, a specific type of diagnostic test--called a companion diagnostic--has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine. This report provides an overview of federal regulation of IVDs by FDA, through the Federal Food, Drug, and Cosmetics Act (FFDCA) and the Public Health Service Act (PHSA), and by CMS, through the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
Contributing Partner: UNT Libraries Government Documents Department
Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship

Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship

Date: June 19, 2000
Creator: Schacht, Wendy H
Description: Interest in methods to provide drugs at lower cost, particularly for the elderly, has rekindled discussion over the role the federal government plays in facilitating the creation of new pharmaceuticals for the marketplace. This report explores the issue of whether or not the substantial federal investment in health-related research and development (R&D) entitles the public to commensurate consideration in prices charged for any resulting drugs. It is intended to provide the reader with an understanding of the rationale for government support of R&D and subsequent efforts to facilitate private sector commercialization of new technologies generated from such work. Concerns surrounding innovation in pharmaceuticals and biotechnology are discussed within the broader context of the federal role in facilitating technological progress.
Contributing Partner: UNT Libraries Government Documents Department
Patent Reform: Issues in the Biomedical and Software Industries

Patent Reform: Issues in the Biomedical and Software Industries

Date: April 7, 2006
Creator: Schacht, Wendy H
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Hatch-Waxman Act: Proposed Legislative Changes

The Hatch-Waxman Act: Proposed Legislative Changes

Date: September 3, 2002
Creator: Schacht, Wendy H & Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

Date: September 17, 2003
Creator: Schacht, Wendy H & Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

Date: October 9, 2003
Creator: Schacht, Wendy H & Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

Date: January 5, 2004
Creator: Schacht, Wendy H & Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

Date: June 30, 2003
Creator: Schacht, Wendy H & Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

Date: July 15, 2003
Creator: Schacht, Wendy H & Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

Date: November 25, 2002
Creator: Schacht, Wendy H & Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

Date: January 16, 2003
Creator: Schacht, Wendy H & Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

Date: April 2, 2003
Creator: Schacht, Wendy H & Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

Date: May 8, 2003
Creator: Schacht, Wendy H & Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents

Date: June 23, 2003
Creator: Schacht, Wendy H & Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship

Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship

Date: February 3, 2009
Creator: Schacht, Wendy H.
Description: This report explores the reasons behind government funding of research and development and subsequent efforts to facilitate private sector commercialization of the results of such work, without addressing issues associated with drug costs or pricing. It particularly looks at the manner in which the National Institutes of Health (NIH) supports research to encourage the development of new pharmaceuticals and therapeutics, particularly through cooperative activities among academia, industry, and government.
Contributing Partner: UNT Libraries Government Documents Department
Follow-On Biologics: Intellectual Property and Innovation Issues

Follow-On Biologics: Intellectual Property and Innovation Issues

Date: August 3, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
Description: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Contributing Partner: UNT Libraries Government Documents Department
Lead-Based Paint Poisoning Prevention: Federal Mandates for Local Government

Lead-Based Paint Poisoning Prevention: Federal Mandates for Local Government

Date: September 11, 1998
Creator: Schierow, Linda-Jo
Description: None
Contributing Partner: UNT Libraries Government Documents Department
Endocrine Disruption: An Introduction

Endocrine Disruption: An Introduction

Date: January 11, 2001
Creator: Schierow, Linda-Jo & Buck, Eugene H
Description: Exposure to certain chemicals in the environment could disrupt the hormone systems of animals and humans, according to some scientists who are concerned about potential risks to public health and ecosystems. Congress has mandated chemical screening to assess the potential of pesticides and drinking water contaminants to influence the normal functions of female, male and thyroid hormones. As conflicting scientific evidence accumluates on the hormone disruption hypothesis, legislators may consider proposals to increase or decrease funding for the endocrine disruption screening program, or to expand its requirements to include additional chemicals or hormone functions.
Contributing Partner: UNT Libraries Government Documents Department