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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News
    TrackersTrackers

    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...
  • Regulatory NewsRegulatory News

    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...
  • FDA Lays out Plan for National Medical Device Surveillance System

    On the eve of several public meetings aimed at reworking the US Food and Drug Administration's (FDA) medical device postmarket surveillance system, the agency has released a new plan it says offers its own roadmap on how to improve safety monitoring of potentially dangerous devices. The report, entitled, " Strengthening our National System for Medical Device Postmarket Surveillance ," proposes four changes to be made to the current system of postmarket surveillance: th...
  • Proposed Medical Device Postmarketing Surveillance System Moves Forward

    Regulators with the US Food and Drug Administration (FDA) want to bolster the surveillance of already-approved medical devices, and are calling for public feedback on what the ideal system for conducting such surveillance might look like. In a 30 August Federal Register posting, FDA noted that, "Several high-profile device performance concerns have led some to question whether the Center for Devices and Radiological Health's (CDRH) current postmarket surveillance ...
  • 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...