US Food and Drug Agency

The field of Process Analysis, and inferential analysis in particular, has received a huge boost in importance by the emphasis that the Center for Drug Evaluation and Research (CDER) within the US Food and Drug Agency (FDA) has given to the use of PAT in the pharmaceutical and biotechnology industries... 

In 2011, Magrabi analysed 46 adverse events which had been submitted to the US Food and Drug Agency (FDA) [58] and classified them by problem type (Table 1.2). Ninety three percent involved CPOE or PACS systems. 

The aluminium content of many foodstuffs has been evaluated by the US Food and Drug Agency (FDA) [2]. In general, vegetables contain more aluminium than meat. For example, small peas contain 0.6 mg of aluminium per 100 g of foodstuff, while chicken contains only 0.5 g of aluminium per 100 g of meat. Tea is particularly high in... 

The release of a new drug onto the market must be approved by the regulating authority for that country. For example, in Britain this is the Medicines Control Agency (MCA), in the European Union it is the European Medicines Evaluation Agency (EMEA) and in the USA the US Food and Drugs Administration (FDA). These bodies, which are essentially consumer protection agencies, issue a so called product licence or marketing authority (MA) when they are satisfied... 

Extraction can be used as an efficient and selective sample preparation method before analysis by chromatographic, spectroscopic, electroanalytical, or electrophoretic methods (see for example [5-10]). International norms from the International Standards Organization, US Food and Drug Administration, and US Environmental Protection Agency recommend application of extraction methods in analysis of food products and environmental and pharmaceutical samples. Novel ideas and new views concerning extraction have led to many controversies about terminology and to reallocation and softening of the boundaries between extraction and other analytical sample treatment techniques. 

See also Clean Air Act (CAA), (US) Clean Water Act (CWA) (US) Environmental Protection Agency (US) Food and Drug Administration (US) Genetically Engineered Foods Lead Mercury Occupational Safety and Health Act, US Organisation for Economic Cooperation and Development Polychlorinated Biphenyls (PCBs) Risk Assessment, Ecological Risk Assessment, Human Health Toxic Substances Control Act. 

Agency US Food and Drug Administration (FDA) Year oe Initiae Enactment 1938, followed by numerous amendments... 

They are the required statutory tests for agencies under such laws as the (US) Eederal Hazardous Substances Act (unless data are already available), (US) Toxic Substances Control Act, (US) Federal Insecticides, Fungicides, and Rodenticides Act, Organization for Economic Co-operation and Development, and the (US) Food and Drug Administration laws. 

---