• 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 ...
  • Bill Proposes National Tracking System for Drug Overdoses

    • 21 August 2012
    The Centers for Disease Control and Prevention (CDC) would be tasked with compiling, analyzing and publishing data on drug overdoses if a new piece of proposed legislation is signed into law. The bill, the Stop Overdose Stat Act (S.O.S. Act) , is more broadly intended to reduce the number of drug overdoses occurring in the US. The bill notes more than 36,000 Americans died from drug overdoses in 2008, with approximately three-in-four of these deaths resulting from a...
  • 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...
  • As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

    A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude's requests to retract an article implying defibrillator leads on St. Jude's Riata products were less safe than previously known, reports various sources. St. Jude had previously released a press release on 6 April calling on the journal to retract the article in light of what it said were "numerous mistakes and oversights," repo...
  • 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...