FDA Releases Draft Guidance on Classifying Significant Postmarket Drug Safety Issues

The Food and Drug Administration released a draft guidance on how it classifies significant postmarket drug safety issues, according to a notice published March 9 in the Federal Register (77 Fed. Reg. 14,402).

Classifying Significant Postmarket Drug Safety Issues establishes a formal framework for assessing the relative urgency of tracked safety issues (TSIs) so that FDA’s Center for Drug Evaluation and Research (CDER) can direct resources more effectively toward the issues that pose the greatest potential risk for patients, the notice said.

FDA said this framework will classify TSIs as “priority” or “standard” for CDER review. In ...