Regulatory Focus™ > News Articles > FDA Releases New Framework for Classifying Postmarket Drug Safety Issues

FDA Releases New Framework for Classifying Postmarket Drug Safety Issues

Posted 08 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration released new draft guidance on 8 March on classifying significant postmarket drug safety issues.

The classification system-a three-tier approach in which postmarket drug safety issues are either classified as standard, priority or emergency-was developed under the Center for Drug Evaluation and Research's (CDER) Safety First Initiative.

The classification system is intended to cover postmarketing safety issues such as serious adverse events, product quality issues and medication errors in order to allow CDER to take a risk-based, resource-efficient approach.

The so-called 'tracked safety issues' (TSIs) are currently subject to a haphazard framework, which FDA notes slows down their ability to respond with properly directed resources in an expeditious manner. Going forward, CDER wants to use a hazard assessment criteria combined with the modulating factors inherent in the situation or product. This will yield either a standard or priority safety designation. If FDA staff believes it is warranted, it may elevate a status to "emergency."


Read more:

FDA - Guidance Classifying Significant Postmarketing Drug Safety Issues

Federal Register - Draft Guidance on Classifying Significant Postmarket Drug Safety Issues; Availability


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