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Health law is a field of law that encompasses federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the health care industry and its patients, and delivery of health care services, with an emphasis on operations, regulatory and transactional issues.
Examples of regulatory agencies that enforce standards include the Food and Drug Administration in the United States and the Medicines and Healthcare products Regulatory Agency in the United Kingdom; and, in the case of economic regulation, the Office of Gas and Electricity Markets and the Telecom Regulatory Authority in India.
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...
A common definition of compliance is:'Observance of external (international and national) laws and regulations, as well as internal norms and procedures, to protect the integrity of the organization, its management and employees with the aim of preventing and controlling risks and the possible damage resulting from these compliance and ...
Federal Mine Safety and Health Act of 1977; Fetus Farming Prohibition Act; Food Additives Amendment of 1958; Food Allergen Labeling and Consumer Protection Act; Food and Drug Administration Amendments Act of 2007; Food and Drug Administration Modernization Act of 1997; Food and Drug Administration Revitalization Act; Federal Food, Drug, and ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The Health Insurance Portability and Accountability Act of 1996 (HIPAA or the Kennedy–Kassebaum Act [1] [2]) is a United States Act of Congress enacted by the 104th United States Congress and signed into law by President Bill Clinton on August 21, 1996. [3]
In the United States, regulation of drugs was originally a state right, as opposed to federal right. But with the increase in fraudulent practices due to private incentives to maximize profits and poor enforcement of state laws, the need for stronger federal regulation increased. [7]