Slight Change in FDA's Drug Safety Communication Plan

The Food and Drug Administration has issued a new guidance document, "Drug Safety Information--FDA's Communication to the Public," explaining how it communicates important drug safety information and the factors influencing when information is communicated. This guidance replaces an earlier version issued in May 2005, when FDA proposed a new communication channel -- the "Drug Watch" Web page -- to provide information on emerging drug safety issues.

The agency said it decided to eliminate the name "Drug Watch" to prevent potential confusion with FDA's existing "MedWatch" of safety alerts.

Jeffrey Shuren, assistant commissioner for Policy, signed the notice that appeared in yesterday's Federal Register.

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    March 2021

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