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The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
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 ...
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]
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 ...
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 ...
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
On the eve of the Republican National Convention, Food and Drug Administration Commissioner Dr. Stephen Hahn announced that the FDA had issued emergency use authorization for investigational ...
By a provider concerning an FDA-regulated product or activity, By an entity required to report to the FDA about the quality, safety, or effectiveness of an FDA-regulated product or activity, or; By a contractor acting on behalf of the FDA or entity for these purposes; Law enforcement — PSWP may be disclosed to law enforcement personnel