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Drug Safety Communications Are Not Crisis Management Tools, FDA Says

 
• By Sue Sutter

A new draft guidance explains the Center for Drug Evaluation and Research’s approach to communicating emerging drug safety information. Since 2010, Drug Safety Communications have replaced a variety of audience-focused tools laid out in a 2007 guidance, but FDA says public health alerts will be used to communicate about products that pose an immediate danger.

FDA’s Drug Safety Communications will not supplant other ways of conveying information about tainted or adulterated drug products that pose a public health threat, the agency said in a new draft guidance that explains the Center for Drug Evaluation and Research’s approach to communicating drug safety information.

Although DSCs communicate important safety information (see box), they are not crisis communication documents, the agency said in the new draft guidance, “Drug Safety Information – FDA’s Communication...

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