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Regulating medicines

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The modern regulation of medicines has been predicated by a series of drug safety disasters. An improperly prepared elixir of the antibiotic sulphanilamide using toxic diethylene glycol as a solvent instead of glycerol, caused the deaths of over 100 patients including children. This led to the introduction of the Food Drugs and Cosmetic Act in the US in 1938, whose purpose was to regulate the purity of prescription medicines.1 The untested administration of thalidomide to thousands of pregnant women in the late 1950s produced deformities in their offspring and resulted in the legal requirement for assessment of the safety and efficacy of new medicines prior to their marketing authorisation.2 More recently, the early clinical trial of the monoclonal antibody TGN 1412 in healthy volunteers led …

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