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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.
Partner: UNT Libraries Government Documents Department
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FDA Regulation of Medical Devices

Description: 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.
Partner: UNT Libraries Government Documents Department
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The FDA Medical Device User Fee Program

Description: This report describes current law regarding medical device user fees, the impact of MDUFA on FDA review time of various medical device program budget, the MUDFA III proposal (legislative language and performance goals agreement), and issues that Congress is likely to take up as it works on the reauthorization of the medical device user fee program.
Date: April 24, 2012
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
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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
Partner: UNT Libraries Government Documents Department
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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.
Partner: UNT Libraries Government Documents Department
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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.
Partner: UNT Libraries Government Documents Department
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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.
Partner: UNT Libraries Government Documents Department
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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
Partner: UNT Libraries Government Documents Department
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Frequently Asked Questions About Prescription Drug Pricing and Policy

Description: This report will address frequently asked questions about government and private-sector policies that affect drug prices and availability. Among the prescription drug topics covered are federally funded research and development, regulation of direct-to-consumer advertising, legal restrictions on reimportation, and federal price negotiation. The report provides a broad overview of the issues as well as references to more in-depth CRS products. The appendixes provide references to relevant congre… more
Date: May 2, 2017
Creator: Kirchhoff, Suzanne M.; Johnson, Judith A. & Thaul, Susan
Partner: UNT Libraries Government Documents Department
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CRISPR Gene Editing Research in Embryos Generates Scientific and Ethics Debate

Description: This report discusses the results of a recent experiment on the use of gene modification for decreasing the chance of children having hypertrophic cardiomyopathy which was done through the use of CRISPR to modify the genes of human embryos at a private facility. Restrictions on the use of public funds for such studies, a brief explanation of the science, and ethical concerns are discussed.
Date: September 12, 2017
Creator: Sargent, John F., Jr.; Sarata, Amanda K. & Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
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FDA Human Medical Product User Fee Programs: In Brief

Description: This report discusses FDA human medical product user fees for prescription drugs, medical devices, generic drugs, and biosimilars which are charged to companies producing the products and make up a large portion of the FDA's revenues. User fees are authorized in legislation on a five-year cycle, with authority for their actual collection and expenditure provided each year through the annual appropriations process. Appendix A outlines various features of the user fee programs.
Date: November 21, 2017
Creator: Dabrowska, Agata; Johnson, Judith A.; Sarata, Amanda K. & Thaul, Susan
Partner: UNT Libraries Government Documents Department
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FDA Authorization Act of 2017 (FDARA, P.L. 115-52)

Description: This report presents an overview of the Food and Drug Administration Reauthorization Act (FDARA) of 2017 by title and section, providing a narrative context for each title, as well as a brief description of each section.
Date: September 21, 2017
Creator: Sarata, Amanda K.; Dabrowska, Agata; Johnson, Judith A. & Thaul, Susan
Partner: UNT Libraries Government Documents Department
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Federal Research and Development Funding: FY2017

Description: This report begins with a discussion of the overall level of the President's FY2017 R&D request, followed by analyses of the R&D funding request from a variety of perspectives and for selected multiagency R&D initiatives. It concludes with discussion and analysis of the R&D budget requests of selected federal departments and agencies that, collectively, account for nearly 99% of total federal R&D funding.
Date: June 24, 2016
Creator: Sargent, John F., Jr.; Esworthy, Robert; Gottron, Frank; Johnson, Judith A.; Monke, Jim; Morgan, Daniel et al.
Partner: UNT Libraries Government Documents Department
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Public Health Service Agencies: Overview and Funding (FY2015-FY2017)

Description: This report gives a brief overview of the eight agencies within the Department of Health and Human Services (HHS) which are designated components of the U.S. Public Health Services (PHS), and summarizes its funding for FY2015 through FY2017.
Date: May 19, 2016
Creator: Redhead, C. S.; Dabrowska, Agata; Bagalman, Erin; Heisler, Elayne J.; Johnson, Judith A.; Lister, Sarah A. et al.
Partner: UNT Libraries Government Documents Department
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Public Health Service Agencies: Overview and Funding (Fiscal Year 2016-Fiscal Year 2018)

Description: This report outlines the funding types received by U.S. Public Health Service agencies and provides brief overviews of each agency and their recent funding trends. The eight agencies discussed are the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), the Agency for Toxic Substances and and Disease Registry (ATSDR), the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS… more
Date: August 16, 2017
Creator: Redhead, C. Stephen; Dabrowska, Agata; Bagalman, Erin; Heisler, Elayne J.; Johnson, Judith A.; Lister, Sarah A. et al.
Partner: UNT Libraries Government Documents Department
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Federal Research and Development Funding: FY2016

Description: This report begins with a discussion of the overall level of the President's FY2016 R&D request, followed by analyses of the R&D funding request from a variety of perspectives and for selected multiagency R&D initiatives. The report concludes with discussion and analysis of the R&D budget requests of selected federal departments and agencies that, collectively, account for more than 98% of total federal R&D funding.
Date: February 11, 2016
Creator: Sargent, John F., Jr.; Esworthy, Robert; Johnson, Judith A.; Monke, Jim; Morgan, Daniel; Moteff, John D. et al.
Partner: UNT Libraries Government Documents Department
open access

Federal Research and Development Funding: FY2017

Description: This report begins with a discussion of the overall level of the President's FY2017 R&D request, followed by analyses of the R&D funding request from a variety of perspectives and for selected multiagency R&D initiatives. It concludes with discussion and analysis of the R&D budget requests of selected federal departments and agencies that, collectively, account for nearly 99% of total federal R&D funding.
Date: January 27, 2017
Creator: Sargent, John F., Jr.; Esworthy, Robert; Harris, Laurie A.; Johnson, Judith A.; Monke, Jim; Morgan, Daniel et al.
Partner: UNT Libraries Government Documents Department
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