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  • Regulatory NewsRegulatory News

    EMA goes all in on big data

    The European Medicines Agency (EMA) and the EU’s Heads of Medicines Agencies (HMA) have issued an ambitious workplan for a joint steering group to tackle issues related to big data in healthcare and medicines development.   The steering group’s 2021-2023 work plan, adopted in June and published Friday, “aims to increase the utility of big data in regulation, from data quality through study methods to assessment and decision-making,” according to EMA’s big data webpage...
  • Regulatory NewsRegulatory News

    Stakeholders weigh in on big data at EMA forum

    Effective use of real-world data and other data gathered outside the clinical trial arena requires a unified, big-picture approach, according to a new report from the first-ever big data stakeholder forum held by the European Medicines Agency (EMA).   The regulator’s report on the 15 December 2020 forum highlighted the importance of collaboration in addressing some of the challenges of bringing real-world data (RWD) into the drug development process. Some of these incl...
  • Regulatory NewsRegulatory News

    EU Taskforce of Pharma Regulators Issues its First Report on Big Data

    A European drug regulators’ taskforce on big data published its first report on Friday. The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) formed the HMA-EMA Joint Big Data Taskforce to harness the potential of data in development and oversight, starting with the new report. They examined clinical trial data, spontaneous adverse drug reports (ADRs), social media data and real-world data (RWD) to inform the work and reach “an important mileston...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System (10 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System A senior politician overseeing the United Kingdom’s exit from the European Union has dismissed the need to retain certain aspects of the country’s current regulatory model post-Brexit. Asked in the House of Commons whether he agreed with industry leaders on the need for the UK to be part of a Europe-...
  • Regulatory NewsRegulatory News

    Is Google a Key Part of the Future of Drug Safety? FDA Researchers Say 'Yes'

    Could the US Food and Drug Administration (FDA) soon use Google to track drug-related adverse events? In a new research letter published this week in Clinical Pharmacology & Therapeutics, two FDA researchers argue that "Internet search logs" could be substantially useful to the agency's drug regulatory staff in determining which drugs might have unforeseen adverse events. Background At present, FDA tracks those adverse events through a hybrid voluntary/mandatory rep...
  • Regulatory NewsRegulatory News

    FDA Launches Big Data 'openFDA' Initiative, Giving Public Easier Access to Safety Information

    The US Food and Drug Administration (FDA) has launched a long-awaited technology initiative intended to free regulatory data that was once difficult to obtain and harder still to make sense of. Background The initiative, known as openFDA, comes in the wake of a May 2012 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and accessible to the public....
  • 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...
  • Survey of Americans Show Trust in Big Pharma Only Slightly Above Faith in Existence of 'Lizard People'

    • 05 April 2013
    Americans don't particularly trust the pharmaceutical industry. But the extent to which that trust deficit exists is on particularly glaring display in a new survey, which shows that more than one in seven Americans think the pharmaceutical industry is colluding to "invent" new diseases in order to profit off them, and 20% erroneously think vaccines cause autism. Survey Results The survey, conducted by the group Public Policy Polling, approached 1,247 registered voters,...
  • Report: As Pharma Goes Global, So Do Charges of Corruption

    • 29 February 2012
    A report by Reuters has found that increasingly global pharmaceutical companies are running up against many of the same charges of influence peddling and corruption abroad that they once faced at home. The charges could affect more than just the companies' reputations. "In recent years, Big Pharma has forked out billions of dollars to settle scandals involving improper promotion of medicines in the United States.  Now bribes paid to foreign doctors and other st...