Experts propose 'P-plating' new drugs.

Australian Doctor,  March, 2007  

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By Helen Carter

MJA A 'P-plate' system for new drugs would more effectively protect consumers from potential harms and save lives, experts say.

In a paper in the Medical Journal of Australia (5 March) they proposed a system of provisional approval with a "Caution, New Medicine" rating system to replace the current system of pre-marketing trials and voluntary adverse event reporting.

Full approval would hinge on Australian post-marketing observational studies proving no excess serious adverse events occurred compared with other drugs, said the paper's co-author, ...

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