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FDA Approval Author: Michael D. Nguyen, MD, Acting Director of the Division of Epidemiology in FDA’s Center for Biologics Evaluation and Research Last Updated: Jul 7, 2016 - 5:36:25 PM



Harnessing the Power of Databases to Evaluate Medical Products

By Michael D. Nguyen, MD, Acting Director of the Division of Epidemiology in FDA’s Center for Biologics Evaluation and Research
Mar 18, 2014 - 1:15:17 PM



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(HealthNewsDigest.com) - Clinical trials are designed to evaluate the safety and effectiveness of medications. But the number of participants in clinical trials represents only a fraction of the number of people who will ultimately use the product after FDA approves it.  Occasionally, rare and unexpected health problems (which we call "adverse events") become apparent only after a medical product is on the market and many more people use it.  That's why it's so important for FDA to continue to monitor the safety of medical products, a practice called surveillance.

Most safety surveillance systems are passive: They rely on health care professionals and consumers to notice and report adverse events. Although these passive systems remain essential, they have certain limitations. For example, health care professionals and consumers might not recognize that the product is the cause of an adverse effect and not report it to FDA.  Or, they might report a suspected adverse event that's not truly the cause of a problem the consumer experiences.

Now imagine if we could actively search more than 100 million health insurance records to uncover possible adverse events, rather than relying on doctors and patients to report them.

Read the entire blog at FDA Voice.

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