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The Sunshine Act requires manufacturers of drugs, medical devices, biological and medical supplies covered by the three federal health care programs Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) to collect and track all financial relationships with physicians and teaching hospitals and to report these data to the Centers for Medicare and Medicaid Services (CMS).
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.
Center for Improvement in Healthcare Quality (CIHQ) [3] Commission on Accreditation of Rehabilitation Facilities (CARF) Community Health Accreditation Program(CHAP) DNV GL Healthcare; Foundation for the Accreditation of Cellular Therapy (FACT) [4] Global Healthcare Accreditation (GHA) [5] Healthcare Facilities Accreditation Program (HFAP)
It amends the Public Health Service Act to require the FDA, acting through the Director of NIH, to expand the clinical trials registry data bank. It requires the Director to ensure that the data bank is made publicly available through the Internet and requires the FDA to ensure that the data bank includes links to results information for those ...
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
The following is a list of the 20 largest settlements reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2013, ordered by the size of the total settlement. The settlement amount includes both the civil (False Claims Act) settlement and criminal fine.
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 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]