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Rules rule

Nature volume 441, pages 1022–1023 (2006)Cite this article

Regulatory affairs is a young profession that's already making its mark in the world of drug development, where one false move can bring years of research to an unwelcome end. If your skills include communication and leadership, it may be for you, says Hannah Hoag.

Last year, global spending on prescription drugs exceeded US$600 billion. Topping the sales list were drugs to combat high cholesterol levels, heartburn, schizophrenia and asthma. But regardless of their sales strength, every drug had one thing in common: each had been scrutinized by regulatory-affairs professionals before reaching the pharmacy shelves. Employed by the drug companies and contract research organizations, these experts assemble huge dossiers of data and oversee the mountain of paperwork required by the regulatory agencies that oversee the industry.

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  1. Hannah Hoag is a freelance writer based in Montreal, Canada.

    • Hannah Hoag
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  1. Hannah Hoag
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Drug hunt

Seeing the big picture

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US Food and Drug Administration

Regulatory Affairs Professionals Society

The Organisation for Professionals in Regulatory Affairs

European Medicines Agency

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Hoag, H. Rules rule. Nature 441, 1022–1023 (2006). https://doi.org/10.1038/nj7096-1022a

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