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Invited Commentary
Nov 26, 2012

New Drug: Caution Indicated: Comment on “New Drugs and Safety”

Author Affiliations

Author Affiliation: Institute for Safe Medication Practices, Horsham, Pennsylvania.

Arch Intern Med. 2012;172(21):1681-1682. doi:10.1001/2013.jamainternmed.610

In assessing a new therapeutic drug, regulators at Health Canada and the US Food and Drug Administration (FDA) are entrusted with making critical and difficult scientific judgments that can affect the health of hundreds of thousands of patients in a matter of months after product launch. In drug evaluation, the cost of error may be high. Casualties in pharmaceutical disasters are measured in tens of thousands, and the population exposed to unsafe drugs often numbers in the millions.1 In a new research letter, Lexchin2 provides a valuable but basic report card for the drug approval decisions at Health Canada over a 16-year period.

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