• Regulatory NewsRegulatory News

    Sentinel, iPod-Based Devices can Match Patients to EHRs in Public Health Emergencies

    A recent study funded by the US Food and Drug Administration (FDA) found that an iPod Touch-based platform and FDA's Sentinel system could be used to accurately track the safety of drugs and vaccines dispensed during public health emergencies. The platform, called the handheld automated notification for drugs and immunizations (HANDI), uses an application running on an iPod touch, fitted with a card reader and barcode scanner, to record patients' information from a drive...
  • Regulatory NewsRegulatory News

    Woodcock: Drug Safety Surveillance System Ready for Full Operation

    The US Food and Drug Administration's (FDA) Sentinel database tracking medical product safety events is now an "integral part of routine safety surveillance," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA said at the 8 th Annual Sentinel Initiative Public Workshop in Washington, DC, Wednesday. "We can, as of today, officially drop 'Mini' from the Sentinel title," she said, noting the progress made since the agency began transition...
  • For First Time Since Founding, Government's Mini-Sentinel System Shrinks in Size

    The US government's Mini-Sentinel adverse event active surveillance system had something unusual happen to it this year: It shrank. Background Mini-Sentinel was created in 2008 as an effort to create a nationwide system to track products regulated by FDA after their approval. With the  Food and Drug Administration Amendments Act (FDAAA)  placing a far greater emphasis on post-approval requirements for drugs (instead of requiring all data to be submitted prio...
  • At 160 Million Patients, FDA's Mini-Sentinel Isn't so 'Mini' Anymore

    Despite its name, Mini-Sentinel , the US Food and Drug Administration's (FDA) ambitious attempt at creating an active surveillance system, isn't so miniature. In fact, according to data released by the project this week, it's positively massive. Background Before we dig into those numbers, some background information is in order. Mini-Sentinel was created in 2008 as an effort to create a nationwide system to track products regulated by FDA after their approval. With ...
  • Woodcock: FDA Time, Resources Now Split Equally Between Premarket, Postmarket Analysis

    Janet Woodcock, Director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), told a meeting of healthcare journalists the agency is heavily invested in tracking postmarketing regulatory issues and has made significant advancements since 2008, reports Reuters . "Our oversight of the safety of marketed drugs has changed significantly over the past few years," said Woodcock in a statement. "This report shows that the quality, acco...
  • Paper Looks to Establish Best Practices for Evaluating Effectiveness of Regulations

    A white paper released by Mini-Sentinel, and adverse event tracking pilot project, evaluates a series of existing studies evaluating the impact of the US Food and Drug Administration's regulatory actions, finding those studies to be largely lacking. The paper, published 12 March and released to the public on 5 April, sought to answer two questions: what regulatory methods have been used by FDA, and what are the best practices for evaluating regulatory actions? The two-p...