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 Collection: Congressional Research Service Reports
The FDA Medical Device User Fee Program: MDUFA IV Reauthorization

The FDA Medical Device User Fee Program: MDUFA IV Reauthorization

Date: June 6, 2016
Creator: Johnson, Judith A.
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.
Contributing Partner: UNT Libraries Government Documents Department
Background and Legal Issues Related to Stem Cell Research

Background and Legal Issues Related to Stem Cell Research

Date: October 26, 2004
Creator: Shimabukuro, Jon O.
Description: This report discusses issues regarding stem cell research. With certain restrictions, the President has announced that federal funds may be used to conduct research on human embryonic stem cells. Federal research is limited to "the more than 60" existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. No federal funds will be used for the derivation or use of stem cell lines derived from newly destroyed embryos; the creation of any human embryos for research purposes; or cloning of human embryos for any purposes.
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Stem Cell Research

Stem Cell Research

Date: December 13, 2004
Creator: Johnson, Judith A. & Williams, Erin
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.
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Overview of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

Overview of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

Date: December 6, 2004
Creator: O'Sullivan, Jennifer; Chaikind, Hinda; Tilson, Sibyl; Boulanger, Jennifer & Morgan, Paulette
Description: This report examines the the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which creates a prescription drug benefit for Medicare beneficiaries and establishes a new Medicare Advantage program to replace the current Medicare+Choice program.
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Title X (Public Health Service Act) Family Planning Program

Title X (Public Health Service Act) Family Planning Program

Date: March 15, 2016
Creator: Napili, Angela
Description: This report discusses various issues regarding the Family Planning Program, Title X of the Public Health Service Act. Enacted in 1970, it is the only domestic federal program devoted solely to family planning and related preventive health services.
Contributing Partner: UNT Libraries Government Documents Department
Pandemic Flu and Medical Biodefense Countermeasure Liability Limitation

Pandemic Flu and Medical Biodefense Countermeasure Liability Limitation

Date: December 5, 2006
Creator: Cohen, Henry
Description: This report analyzes Division C of the Department of Defense Emergency Supplemental Appropriations, P.L. 109-148, which was signed into law on December 30, 2005, and which limits liability with respect to pandemic flu and other public health countermeasures.
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Medicare Prescription Drug Proposals: Estimates of Aged Beneficiaries Who Fall Below Income Criteria, by State

Medicare Prescription Drug Proposals: Estimates of Aged Beneficiaries Who Fall Below Income Criteria, by State

Date: February 11, 2003
Creator: Peterson, Chris L. & Morgan, Paulette C.
Description: This report discusses bills related to Medicare benefits, which include additional assistance for low-income beneficiaries. The assistance would have been in the form of reduced, subsidized or eliminated premiums, deductibles and other cost-sharing. Proposals in the 108th Congress will probably also include some of these features for low-income beneficiaries.
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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.
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Veterans' Health Care Issues in the 109th Congress

Veterans' Health Care Issues in the 109th Congress

Date: June 27, 2005
Creator: Panangala, Sidath V.
Description: This report provides an overview of major issues facing veterans' health care during the 109th Congress. The report's primary focus is on veterans and not military retirees.
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Stem Cell Research

Stem Cell Research

Date: August 13, 2004
Creator: Johnson, Judith A. & Williams, Erin
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.
Contributing Partner: UNT Libraries Government Documents Department
Medical Malpractice Liability Reform: H.R. 5, 109th Congress

Medical Malpractice Liability Reform: H.R. 5, 109th Congress

Date: January 18, 2006
Creator: Cohen, Henry
Description: This report discusses H.R. 5, which would preempt state law regarding some aspects of medical malpractice liability and liability for defective medical products, including drugs. The legislation would among other things, place caps on noneconomic and punitive damages (in states that have not enacted and do not enact caps), eliminate joint and several liability, modify the collateral source rule, limit lawyers' contingent fees, enact a federal statute of limitations, and provide for periodic payment of future damages.
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Human Cloning

Human Cloning

Date: July 20, 2006
Creator: Johnson, Judith A. & Williams, Erin D.
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.
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The Veterans Health Administration and Medical Education: A Fact Sheet

The Veterans Health Administration and Medical Education: A Fact Sheet

Date: January 19, 2016
Creator: Heisler, Elayne J. & Panangala, Sidath V.
Description: This report supplies facts about the Veterans Health Administration and its medical education. It describes the US Department of Veterans Affairs (VA) and its involvement in the medical training of health care professionals. The report also gives details on the VA's academic affiliations, its funding of physician training, and its ongoing graduate medical education (GME) expansion. Figure 1 on page 3 shows the amount the VA spent on education and training from FY2010 to FY2015.
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Health Care for Veterans: Suicide Prevention

Health Care for Veterans: Suicide Prevention

Date: February 23, 2016
Creator: Bagalman, Erin
Description: This report focuses on suicide prevention activities of the Veterans Health Administration (VHA) within the Department of Veterans Affairs (VA). The VHA's approach to suicide prevention is based on a public health framework, which has three major components: (1) surveillance, (2) risk and protective factors, and (3) interventions.
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Military Medical Care Services: Questions and Answers

Military Medical Care Services: Questions and Answers

Date: January 26, 2005
Creator: Best, Richard A., Jr.
Description: This report attempts to answer basic questions about the Military Health Services System (MHSS), its beneficiary population, the medical services it provides, its costs, and major changes that are underway or have been proposed. Citations are made to more detailed CRS studies where appropriate.
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Smallpox Vaccine Injury Compensation

Smallpox Vaccine Injury Compensation

Date: June 13, 2003
Creator: Thaul, Susan
Description: This report discusses the Public Safety Officers’ Benefits Program, which provides for compensation of individuals injured by vaccinations given as part of a countermeasure plan declared by the Secretary of Health and Human Services in preparation for potential hostile activities involving the smallpox virus.
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.
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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
Pharmaceutical Supply Chain Security

Pharmaceutical Supply Chain Security

Date: October 31, 2013
Creator: Thaul, Susan
Description: This report serves as a primer on pharmaceutical supply chain issues. It (1) describes the chain from manufacturer to patient, including where it is vulnerable; (2) summarizes current federal law, regulation, and FDA policies that Congress and the agency designed to protect the integrity of the final drug product, and indicates where those protections may falter; (3) notes state-level and professional association activities; and (4) discusses areas that Congress, FDA, and industry, health care, and patient stakeholders have suggested might be changed to increase the security of the pharmaceutical supply chain.
Contributing Partner: UNT Libraries Government Documents Department
Patient Safety: Legislation to Promote Voluntary Reporting of Medical Errors

Patient Safety: Legislation to Promote Voluntary Reporting of Medical Errors

Date: November 26, 2003
Creator: Redhead, C. S.
Description: This report provides an overview and some analysis of the patient safety legislation that is being considered by the 108th Congress. It begins with background information on the nature and causes of medical errors, followed by a brief comparison of the differences between mandatory and voluntary reporting systems. The report then discusses some of the legal and policy issues facing state mandatory reporting systems and major national voluntary reporting systems, and identifies design features of effective reporting programs. It concludes with a discussion and side-by-side comparison of H.R. 663 and S. 720.
Contributing Partner: UNT Libraries Government Documents Department
Title X (Public Health Service Act) Family Planning Program

Title X (Public Health Service Act) Family Planning Program

Date: March 25, 2011
Creator: Napili, Angela
Description: This report discusses the Family Planning Program, Title X of the Public Health Service Act, through which the federal government provides grants for voluntary family planning services.
Contributing Partner: UNT Libraries Government Documents Department
Influenza Antiviral Drugs and Patent Law Issues

Influenza Antiviral Drugs and Patent Law Issues

Date: August 16, 2007
Creator: Yeh, Brian T.
Description: This report examines the role that intellectual property rights play in affecting the availability of a patented drug such as Tamiflu during public health crises. The report also explains one legal mechanism for increasing a patented drug’s production without the patent holder’s consent: governments may abrogate a pharmaceutical company’s patent rights by issuing compulsory licenses to other drug companies to manufacture generic versions of the drug.
Contributing Partner: UNT Libraries Government Documents Department
FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

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

Date: December 2, 2008
Creator: Thaul, Susan
Description: The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs—the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003—and enacted a new law addressing devices—the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.
Contributing Partner: UNT Libraries Government Documents Department
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