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Regulatory focus theory (RFT) is a theory of goal pursuit [1]: 444 formulated by Columbia University psychology professor and researcher E. Tory Higgins regarding people's motivations and perceptions in judgment and decision making processes.
A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing ...
MedDRA is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans. It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale.
The PMAG may seek additional expertise and/or input from other national health care organizations, as necessary, for the development of Category II codes. These may include national medical specialty societies, other national health care professional associations, accrediting bodies and federal regulatory agencies.
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” [1] whose goal was the standardization of medical device regulation across the world.
Some of them are MeSH (Medical Subject Headings), COSTART (Coding Symbols for Thesaurus of Adverse Reaction Terms) or MedDRA (Medical Dictionary for Regulatory Activities) [5] Other systems like Current Procedural Terminology do not deal directly with diseases but with the related procedures. [citation needed]
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
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]