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The FDA Medical Device User Fee Program: MDUFA IV Reauthorization

Description: This report describes current law regarding medical device user fees, the impact of Medical Device User Fee and Modernization Act (MDUFMA) on Federal Drug Administration (FDA) review time of various medical device applications, and the agency's medical device program budget.
Date: June 6, 2016
Creator: Johnson, Judith A.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

AIDS Funding for Federal Government Programs: FY1981-FY2009

Description: This report provides an overview of Department of Health and Human Services (HHS) spending on HIV/AIDS (human immunodeficiency virus/acquired immune deficiency syndrome) as well as budget numbers for other federal government programs targeting HIV/AIDS.
Date: April 23, 2008
Creator: Johnson, Judith A.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

FDA Regulation of Follow-On Biologics

Description: This report provides a brief introduction to the relevant law regarding follow-on biologics, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a description of the proposed legislation.
Date: February 24, 2009
Creator: Johnson, Judith A.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

NIH Funding: FY1994-FY2019

Description: This report discusses funding for the U.S. National Institutes of Health (NIH) from 1994 to 2019. The NIH is the primary federal agency charged with conducting and supporting biomedical and behavioral research. It is the largest of the eight health-related agencies that make up the Public Health Service (PHS) within the Department of Health and Human Services (HHS).
Date: October 15, 2018
Creator: Johnson, Judith A. & Sekar, Kavya
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Stem Cell Research

Description: This report provides background on the research and potential applications of research that uses embryonic and adult stem cells. It also provides information about the current federal and state regulatory landscape, related Congressional and international actions, and relevant ethical concerns.
Date: December 13, 2004
Creator: Johnson, Judith A. & Williams, Erin
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Stem Cell Research

Description: This report provides background on the research and potential applications of research that uses embryonic and adult stem cells. It also provides information about the current federal and state regulatory landscape, related Congressional and international actions, and relevant ethical concerns.
Date: August 13, 2004
Creator: Johnson, Judith A. & Williams, Erin
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

AIDS: Ryan White CARE Act

Description: This report discusses the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, which makes federal funds available to metropolitan areas and states to assist in health care costs and support services for individuals and families affected by the human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). This report discusses related legislation and appropriations.
Date: February 17, 2005
Creator: Johnson, Judith A. & Morgan, Paulette C.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Emergency Contraception: Plan B

Description: This report discusses the FDA approval of Plan B as a prescription drug, as well as the more recent and controversial FDA approval of Plan B as an OTC drug. Legal issues regarding the recent FDA decision are also discussed as well as various state policies that affect access to emergency contraceptives. In addition, the report discusses the Department of Justice guidelines for the treatment of sexual assault victims, which have been criticized by numerous organizations because they do not menti… more
Date: August 1, 2007
Creator: Johnson, Judith A. & Burrows, Vanessa K.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

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

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… more
Date: December 17, 2014
Creator: Sarata, Amanda K. & Johnson, Judith A.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

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

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-… more
Date: March 27, 2014
Creator: Sarata, Amanda K.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Human Cloning

Description: This report discusses human cloning science and federal policy regarding human embryo research. It provides background on the topic, federal policies, state laws, Congressional actions, and ethical issues.
Date: July 20, 2006
Creator: Johnson, Judith A. & Williams, Erin D.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

AIDS: The Ryan White CARE Act

Description: This report discusses the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, which makes federal funds available to metropolitan areas and states to assist in health care costs and support services for individuals and families affected by the human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). This report discusses related legislation and appropriations.
Date: June 7, 2006
Creator: Johnson, Judith A. & Morgan, Paulette C.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

The Ryan White HIV/AIDS Program: Overview and Impact of the Affordable Care Act

Description: This report discusses the impact of the Affordable Care Act on the Ryan White HIV/AIDS Program, which makes federal funds available to metropolitan areas and states to that provide a number of health care services for HIV/AIDS patients.
Date: December 21, 2015
Creator: Johnson, Judith A. & Heisler, Elayne J.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Stem Cell Research: Ethical Issues

Description: This report discusses the ethical arguments that surround human embryonic stem cell research (ESR). Human stem cell research is controversial not because of its goals, but rather because of the means of obtaining some of the cells.
Date: April 28, 2009
Creator: Williams, Erin D. & Johnson, Judith A.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

H.R. 6: The 21st Century Cures Act

Description: Report about H.R. 6, the 21st Century Cures Act, which would reauthorize the National Institutes of Health (NIH) through FY2018 and provide other funding to the agency through FY2020.
Date: July 8, 2015
Creator: Johnson, Judith A.; Thaul, Susan & Bagalman, Erin
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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