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    FDA Finalizes Guidance on Postmarket Device Surveillance

    The US Food and Drug Administration (FDA) on Friday finalized guidance (five years after draft guidance was first released) for device manufacturers on its interpretation of the law with regard to postmarket surveillance of certain class II or class III devices. The guidance comes as the Government Accountability Office (GAO) said last October that 90% of the postmarket surveillance studies FDA ordered over the past seven years were categorized as inactive, though some...
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    Plans for US Evaluation System for Medical Devices Take Root

    The US Food and Drug Administration (FDA) is going to make a big push over the next two years to use more real-world evidence to track the safety of medical devices. The plan, outlined in FDA’s Center for Devices and Radiological Health’s (CDRH) Strategic Priorities report for 2016-2017, will see the agency building a national medical device evaluation system as part of efforts to leverage real-world evidence to more quickly identify safety signals, particularly through ...
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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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    FDA Substantially Increasing its Inspections of Foreign Generic Drug Companies

    The US Food and Drug Administration (FDA) has made substantial improvements to its inspections of foreign generic pharmaceutical manufacturers, a new report by the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) claims. Background OIG's report, issued on 4 May 2015, was prompted by congressional concerns that FDA lacked sufficient resources to inspect generic pharmaceutical manufacturers, which now make up nearly 80% of the prescript...
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    In Fight Against Antimicrobial Resistance, EMA Looks to Public for Help

    The European Medicines Agency (EMA) is looking for feedback on a new set of principles for setting the defined daily dose (DDDA) and defined course dose (DCDA) for antimicrobial products used in animals. The guideline was drafted by the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) committee, and is intended to establish standards for setting DDDA and DCDA amounts for veterinary antimicrobial products. The consultation is part of an ongoing...
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    Regulators, Experts Outline Plan for New National Medical Device Surveillance System

    Medical devices—and the patients who use them—would substantially benefit from a National Medical Device Postmarket Surveillance System (MDS), charges a new report authored by the Brookings Institution's Engelberg Center for Health Reform with support from the US Food and Drug Administration (FDA). Background The report, Strengthening Patient Care: Building an Effective National Medical Device Surveillance System , comes nearly three years after FDA's Center for ...
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    9 Free Tools Regulatory Professionals Can use to Monitor the Regulatory Landscape

    It can be profoundly difficult to monitor—let alone make sense of—the regulatory affairs environment. Thanks to constantly changing laws, regulations, policies, legal developments, technologies and sources of information, regulatory professionals need all the help they can get to conduct regulatory surveillance. Luckily, even for regulatory professionals without a budget, there are several free tools and websites that can help you find information, stay ahead of your pee...
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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 Seeks to Broaden Collection of Prescribing Data in Bid to Track Use, Safety of Drugs

    US regulators are laying the groundwork to potentially monitor the use of drugs by patients discharged by healthcare facilities, mirroring and expanding upon other planned activities. Background In June 2013, the US Food and Drug Administration (FDA) announced that it was seeking access to data on adult and pediatric utilization of drugs used in inpatient and emergency settings. The intent, FDA said, was to better conduct postmarket surveillance on the safety of phar...
  • FDA's Adverse Event and Postmarketing Surveillance Efforts get Major Data Boost

    The US Food and Drug Administration's (FDA) efforts to keep track of adverse events and medical outcomes is about to become even more robust thanks to the inclusion of the US' largest healthcare provider into its databases. That provider isn't a private insurer or company-it's the Department of Veterans Affairs' (VA) Veterans Health Administration ( VHA ), which serves nearly 9 million veterans each year at more than 1,700 facilities in the US. As part of VHA's mission,...
  • Regulators Reach out to Private Sector in Bid to Improve Postmarket Surveillance

    The US Food and Drug Administration (FDA) is reaching out to the private sector in a bid to help it improve the quality of the postmarketing surveillance data it receives regarding biologic drugs and products, saying new tools are needed to account for time-contingent variables. The agency's market research notice, posted on 17 May 2013, calls for private-sector support for a problem now plaguing its Center for Biologics Evaluation and Research (CBER). That problem, it e...