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US FDA's Expectations and Firms’ Responsibilities Clarified in Voluntary Recalls Final Guidance, HBW Insight

March 03, 2022

Partner Rebecca Dandeker spoke to HBW Insight about the Food and Drug Administration’s (FDA’s) final guidance for marketers, outlining how to respond voluntarily to recalls of food, drug, medical technology, and personal care products. In the final guidance, the "FDA also clarifies information that was 'intuitive' to industry, but it is helpful to have it confirmed by FDA in writing," Rebecca said, adding that the agency has also provided better explanation of its expectations for communicating recalls. "FDA specifies that emails and 'electronic communications' are appropriate for notifying direct accounts about voluntary recalls, and even states that it 'encourages' those types of communications," she said.

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