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.
This report discusses concerns about food safety, the resources required to ensure food safety, and whether federal food safety laws themselves, first enacted in the early 1900s, have kept pace with the significant changes that have occurred in the food production, processing, and marketing sectors since then.
This report examines these proposals as well as the “Medicare Rx Drug Benefit and Discount Act of 2003,” which was introduced by Representative Charles Rangel, the ranking member of the House Ways and Means Committee. Specifically, this report provides background on how the cost-sharing and premium provisions under each bill would affect the amount that a beneficiary pays annually for prescription drugs.
This report discusses issues regarding genetically engineered soybeans in South America. U.S. soybean growers and trade officials charge that Argentina and Brazil–the United States’ two major export competitors in international soybean markets–gain an unfair trade advantage by routinely saving genetically-engineered (GE), Roundup Ready (RR) soybean seeds from the previous harvest (a practice prohibited in the United States) for planting in subsequent years.
This report is a guide to one of the regular appropriations bills that Congress considers each year. It is designed to supplement the information provided by the House Military Quality of Life and Veterans Affairs and Senate Military Construction and Veterans Affairs Appropriations Subcommittees. It summarizes the status of the bill, its scope, major issues, funding levels, and related congressional activity, and is updated as events warrant.