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    FDA to Soon Require Medical Device Companies to Submit Adverse Event Data Electronically

    The US Food and Drug Administration (FDA) is reminding manufacturers and importers of medical devices about an upcoming requirement to submit all adverse event reports electronically. Background The shift was made final in February 2014 under a final rule, Medical Device Reporting: Electronic Submission Requirements . While medical device manufacturers have long been required under 21 CFR 803 to report known or suspected adverse events to FDA, the regulator has tra...
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    Plain Language Labeling Regulations to Take Effect in Canada

    Health Canada has released a new guidance document intended to clarify new "plain language" labeling requirements before new regulations take effect on 13 June 2015. Background In 2013, Canada's then-Minister of Health Leona Aglukkaq announced the government was launching a new initiative toimprove drug safety by making product information easier to understand for consumers. Making labels and packaging easier to understand, Aglukkaq said, would "help prevent advers...
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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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    WHO Makes Drug Side Effects Easier to Find With New Database

    Last week, the World Health Organization (WHO) boosted its transparency efforts with the launch of a new, open access drug safety database called VigiAccess. Background The practice of postmarket drug monitoring, or pharmacovigilance, is an important part of ensuring patient safety after a product has been approved. During clinical trials, it is not possible to determine every possible side effect or reaction to a drug or vaccine. By monitoring drugs and collecting re...
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    EU Committee Takes on Adverse Event Reporting for Veterinary Drugs

    Regulators at the European Medicines Agency (EMA) are concerned that adverse events may be underreported for veterinary drugs. In an effort to address the issue, the agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has published a reflection paper intended to boost adverse event reporting. Background EMA, along with national regulators, is tasked with monitoring and collecting post-market surveillance data on veterinary medicines. This is done prima...
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    FDA, CDC Preparing Updated Form to Record Vaccination Problems

    The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form. Background In a notice published in the Federal Register on 24 November 2014, CDC said it's accepting public input on its proposed Vaccine Adverse Event Reporting System (VAERS) 2.0 form. VAERS is used by FDA and CDC, which co-administer th...
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    FDA, CDC Put $18M Behind Adverse Event System for Vaccines

    The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have awarded a new, $18 million contract meant to support its existing Vaccine Adverse Event Reporting System (VAERS) over the next five years. The award will go to Virginia-based SRA International, the company announced in a 17 November 2014 press release . SRA has supported FDA's VAERS program since 1999, it said. VAERS is used by FDA to collect and analyze reports of vacci...
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    In New Transparency Bid, EMA Expands Drug Adverse Event Reporting Database

    The European Medicines Agency (EMA) is making it easier for patients and industry to keep track of adverse events associated with medicines authorized for use by EMA and other national drug regulatory authorities. Under a massive expansion of EMA's existing ADRreports.EU website, which houses the European database of suspected adverse drug reaction (ADR) reports, consumers can now view suspected ADR reports for drugs regardless of their centrally authorized approval st...
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    Australia’s TGA Launches Web-based ADR Reporting

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) has launched a web-based medicines and vaccine related adverse event (adverse drug reaction, or ADR) reporting system for the use of consumers. The new web-based reporting service is one of a range of TGA initiative...
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    New Updates to FDA's Website Make it Easier to Track Device Recalls, Drug Changes

    US regulators have announced the release of a treasure trove of data regarding medical device recalls and drug labeling, the latest releases under the US Food and Drug Administration's (FDA) new openFDA program. Background The openFDA initiative was born from a May 2013 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. At th...
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    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...
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    FDA Recommends Against Use of Painkillers for Teething Pain

    US Food and Drug Administration (FDA) regulators are warning that young children who are teething and experiencing pain should not be given lidocaine, a topical painkiller, due to the serious and even fatal risks associated with the drug. In a 26 June announcement , FDA said that the application of oral viscous lidocaine 2% solution had been associated with at least 22 reports of serious adverse reactions, "including deaths," in young children and infants. At leas...