Drug Safety Communications Are Not Crisis Management Tools, FDA Says
Executive Summary
A new draft guidance explains the Center for Drug Evaluation and Research’s approach to communicating emerging drug safety information.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.
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CDER To Pilot Test New Framework For Classifying Drug Safety Issues
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