FDA-TRACK Update: Check out CDER's timely recall classification
On Track: The FDA-TRACK Monthly Newsletter
Learn More: CDER's Drug Recall Classification
A recall is an action taken by a firm to remove product(s) from the market. It may be conducted by a firm's own initiative, by FDA request, or by FDA order under statutory authority. FDA classifies recalls based on the level of health risk of the product, with a Class I recall being the most serious in which the product may cause serious adverse health consequence. The Center for Drug Evaluation and Research (CDER) has a performance measure in FDA-TRACK to track and improve its recall classification timeliness.
In late 2013, CDER's target to recommend and classify drug recalls to Class I within the designated timeframe was increased from 85% to 90% because the Center has placed a higher priority on classifying very serious health consequence recalls compared to recalls that involve less serious consequences. The trend in achieving this 90% target has been steady – in fact, the Center has been hitting 100% for about a year. To continue tracking this progress, visit the FDA-TRACK CDER Dashboard.
What's New in March 2014
New performance data are available for the dashboards below.
CDER Dashboard: CDER completed its Characterization of Biologically Derived Drug Products project to develop and evaluate various analytical methods to assessphysicochemical attributes of biologically derived drug products that affect function. The project was able to provide background about key manufacturing and product attributes that impact clinical efficacy and safety. Results were shared through seven publications and several external presentations.