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The act also allows drug companies to provide economic information about their products to formulary committees, managed care organizations, and similar large-scale buyers of health-care products. The law, however, does not permit the spreading of economic information that could affect prescribing choices to individual medical practitioners. [8]
Health Center Consolidation Act; Health Information Technology for Economic and Clinical Health Act; Health Insurance Portability and Accountability Act; Health Maintenance Organization Act of 1973; Healthcare Quality Improvement Act; Healthy Meals for Healthy Americans Act of 1994; Hematological Cancer Research Investment and Education Act ...
It requires the FDA to submit an annual report to congressional committees that includes: (1) the number of devices approved in the preceding year for which there is a pediatric subpopulation that suffers from the disease; (2) the number of approved devices labeled for use in pediatric patients; (3) the number of fee-exempt devices approved ...
Part of the problem was the CAFC's decision in Roche Products, Inc. v. Bolar Pharmaceutical Co., which interpreted existing U.S. law as prohibiting generic competitors from performing tests required for FDA approval using patented methods, until the patents expired. [2] In response, the Hatch-Waxman Act was negotiated and enacted. [3]
U.S. FDA approves Gilead's long-acting HIV drug Sunlenca December 22, 2022 at 11:26 AM FILE PHOTO: The logo of Gilead Sciences Inc pharmaceutical company is seen in Oceanside, California
Alipogene tiparvovec (Glybera): AAV-based treatment for lipoprotein lipase deficiency (no longer commercially available); Axicabtagene ciloleucel (Yescarta): treatment for large B-cell lymphoma [1]
U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with the AIDS virus. Thursday’s approval of ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...