FDA Issues Guidance Update on Communication to the Public about Drug Safety

This post was written by Erin A. Janssen.

The FDA has released draft guidance entitled “Drug Safety Information—FDA’s Communication to the Public,” which updates and revises March 2007 guidance on this issue.  It describes FDA’s current approach to communicating to the public important drug safety information, including emerging drug safety information, and the factors that influence when the information is communicated. In recent years, FDA has opted to make information on potential drug risks available to the public earlier, often while the Agency is still evaluating the data and determining whether any action is warranted. In the guidance, FDA expresses the belief that timely communication of important drug safety information will give health care professionals, patients, consumers, and other interested persons access to the most current information concerning the potential risks and benefits of a marketed drug, helping them to make more informed individual treatment choices. Written comments on the draft guidance should be submitted by May 8, 2012.

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