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    FDA Lacks Reliable, Accessible Postmarket Data on Drugs, GAO Says

    The US Food and Drug Administration (FDA) does not have reliable, readily accessible data on safety issues and postmarket studies for drugs approved through expedited review pathways, the Government Accountability Office said in a report released Thursday. The report dug into FDA’s Center for Drug Evaluation and Research (CDER) data, which received about 1,000 requests for fast track designation and breakthrough therapy designation (the other two expedited programs for r...
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    GAO Finds Majority of Postmarket Surveillance Studies FDA Ordered for Devices are Inactive

    Nearly 90% of the postmarket surveillance studies the US Food and Drug Administration (FDA) ordered over the past seven years were categorized as inactive, though some of these studies were added to other ongoing studies, according to a new Government Accountability Office (GAO) report. Rep. Rosa DeLauro (D-CT) requested the GAO look into the postmarket studies of devices ordered by FDA, and this latest report investigates the types of devices for which FDA has ordered a...
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    Critics Call for Canada to Bolster New Drug Safety Law, Clarify Reporting Requirements

    A critic of Canada's Protecting Canadians from Unsafe Drugs Act —commonly known as Vanessa's Law —argues that without improvements to the country's adverse drug reaction (ADR) reporting systems, the law will fail to meet its goal of improving drug safety. Background Vanessa's Law came into effect on 6 November 2014, after years of campaigning for stricter drug monitoring mechanisms by Conservative Member of Parliament Terence Young. The law was named for Young's d...
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    EMA Establishes Pharmacovigilance Framework for New Literature Monitoring Efforts

    In regulatory circles, reading literature isn't something that's necessarily done for fun. Instead, regulatory professionals are frequently charged with reading up on the latest literature—scientific literature, that is—mentioning their products in the hopes of discovering reports of dangerous side effects or other potential problems, such as mix-ups or inadequate use or abuse. Background Regulators use reports based on this literature differently. In most regions...
  • FDA Releases New Framework for Classifying Postmarket Drug Safety Issues

    The US Food and Drug Administration released new draft guidance on 8 March on classifying significant postmarket drug safety issues . The classification system-a three-tier approach in which postmarket drug safety issues are either classified as standard, priority or emergency-was developed under the Center for Drug Evaluation and Research's (CDER) Safety First Initiative . The classification system is intended to cover postmarketing safety issues such as serious adve...