You limited your search to:

 Collection: Congressional Research Service Reports
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
Military Medical Care: Questions and Answers

Military Medical Care: Questions and Answers

Date: October 31, 2008
Creator: Jansen, Don J.
Description: This report answers several frequently-asked questions about military health care, particularly related to TRICARE and its various aspects.
Contributing Partner: UNT Libraries Government Documents Department
The 2009 Influenza A(H1N1) "Swine Flu" Outbreak: U.S. Responses to Global Human Cases

The 2009 Influenza A(H1N1) "Swine Flu" Outbreak: U.S. Responses to Global Human Cases

Date: May 26, 2008
Creator: Salaam-Blyther, Tiaji
Description: This report discusses the April 2009 outbreak of the influenza strain known as H1N1, or swine influenza. This report describes the distribution of the virus and the statistics of affected areas, as well as international and U.S. efforts to treat infected persons, respond to outbreaks in various countries, and prepare for a possible influenza pandemic.
Contributing Partner: UNT Libraries Government Documents Department
The Ryan White HIV/AIDS Program: Overview and Impact of the Affordable Care Act

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

Date: December 21, 2015
Creator: Johnson, Judith A. & Heisler, Elayne J.
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.
Contributing Partner: UNT Libraries Government Documents Department
Former NFL Players: Disabilities, Benefits, and Related Issues

Former NFL Players: Disabilities, Benefits, and Related Issues

Date: April 8, 2008
Creator: Halchin, L. Elaine
Description: This report discusses professional football players' injuries and health conditions that might have long-term consequences for their health.
Contributing Partner: UNT Libraries Government Documents Department
Military Medical Care: Questions and Answers

Military Medical Care: Questions and Answers

Date: August 4, 2008
Creator: Best, Richard A., Jr.
Description: This report answers several frequently-asked questions about military health care, including: how the system is structured, a TRICARE summary, TRICARE eligibility and plan options, cost of military health care to beneficiaries, relationship of TRICARE to MEDICARE, how the Affordable Care Act affects TRICARE, long-term trends of defense health care costs, and a summary of the fund which funds TRICARE (the Medicare Eligible Retiree Health Care fund).
Contributing Partner: UNT Libraries Government Documents Department
The 2009 H1N1 "Swine Flu" Outbreak: An Overview

The 2009 H1N1 "Swine Flu" Outbreak: An Overview

Date: April 30, 2009
Creator: Lister, Sarah A. & Redhead, C. S.
Description: This report provides an introduction to the situation regarding the potential of a global human influenza pandemic caused by the new H1N1 flu strain. It includes a brief chronology of events; a discussion of key actions taken and authorities invoked by the WHO and the U.S. government; and information about key U.S. government pandemic flu planning documents.
Contributing Partner: UNT Libraries Government Documents Department
The 2009 Influenza A (H1N1) "Swine Flu" Outbreak: An Overview

The 2009 Influenza A (H1N1) "Swine Flu" Outbreak: An Overview

Date: May 5, 2009
Creator: Lister, Sarah A. & Redhead, C. S.
Description: This report provides an overview of key actions taken and authorities invoked by WHO and the U.S. government. First, it discusses the WHO process to determine the phase of a threatened or emerging flu pandemic and touches on a number of related issues. The report then examines actions taken by the Departments of Homeland Security and Health and Human Services and provides information about appropriations and funding for pandemic flu activities.
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
Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Date: February 10, 2009
Creator: Lister, Sarah A.
Description: This report summarizes key issues in domestic public health and medical preparedness and response, citing other CRS Reports and sources of additional information. Key recent events--the 2001 terrorist attacks, Hurricane Katrina, and concerns about an influenza ("flu") pandemic, among others--sharpened congressional interest in the nation's systems to track and respond to public health threats.
Contributing Partner: UNT Libraries Government Documents Department