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# NEJM Perspective Touts Sentinel Success After 10 Years
- URL: https://www.fdaweb.com/nejm-perspective-touts-sentinel-success-after-10-years/
- Published: 2018-11-30T12:00:00.000Z
- Updated: 2026-09-15T00:47:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142933

Ten years after launching FDA’s Sentinel medical product safety system, officials are lauding its achievements and future potential. An 11/29 *New England Journal of Medicine* [online perspective](https://www.nejm.org/doi/full/10.1056/NEJMp1809643?ref=fdaweb.com) notes that Sentinel data are being integrated to inform many CDER regulatory decisions. For example, in the past two years, Sentinel data “eliminated the need for post-marketing studies on nine potential safety issues associated with five products (e.g., ustekinu-mab and serious infections),” the perspective says. Such post-marketing studies typically require years to design and complete, each at a cost of millions of dollars, it adds.

FDA has also used Sentinel provide more insight into patterns of opioid use and other medical products, including whether they are used for approved indications and “how they are used during pregnancy, to quantify the rate of medication errors, and to assess the effects of medical countermeasures used in public health emergencies,” the perspective says. “All drug-evaluation protocols are posted on the Sentinel Initiative public Web site for comment, as are completed analyses. Starting this year, fully executable programs and standardized specifications for all analyses will be posted, which will enable replication in other environments.”

Future Sentinel enhancements will see improved capabilities and will use new data sources and methods, FDA says. It will be providing “data and expertise to support the incorporation of real-world data into regulatory decision making in other areas in addition to safety assessments,” adds the perspective. “To complement existing Sentinel capabilities, the FDA is also building separate programs tailored to the distinct data needs of its Center for Biologics Evaluation and Research and its Center for Devices and Radiological Health.”