FDA Draft Guidance on Classifying Significant Postmarket Drug Safety Issues

This post was written by Erin A. Janssen.

The FDA has released draft guidance entitled “Classifying Significant Postmarket Drug Safety Issues.”  This draft guidance describes FDA’s current approach to classifying a significant postmarket drug safety issue as a “priority” tracked safety issue (TSI) or a “standard” TSI, with the capability of elevating some priority TSIs to an “emergency” status. The Center for Drug Evaluation and Research seeks to establish a formal framework for assessing the relative urgency of TSIs, so that CDER can direct resources more effectively toward the issues that pose the greatest potential risk for patients. This framework will classify TSIs as “priority” or “standard” for CDER review. In addition, the Center will recognize a special “emergency” category for certain priority TSIs. The use of a formal framework is intended to ensure that staff working in different offices across CDER reaches similar conclusions about the relative urgency of TSIs. It also will inform CDER decisions about public drug safety communications, so that health care practitioners and patients receive timely information about safety risks with the greatest public health significance. Written comments are due May 8, 2012.

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