Researcher finds black-box drugs have high Warning Letter risk

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Drugmakers looking for wiggle room should keep such hopes far from any drugs with a boxed warning. Eye on the FDA took a look at the Warning Letter trends from 2004 through 2012 and found that the government agency is more likely to hit a drugmaker over materials associated with black-box drugs with a Warning Letter rather than with the less-intense untitled letter.

The blogger found that Warning Letters accounted for 34% of the FDA's Warning and Untitled letters, and that 45% of those Warning Letters were for drugs with black-box warnings, while box-free drugs accounted for 32% of the Warning Letters.

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