• Regulatory NewsRegulatory News

    Making Sense of FAERS: Researchers Suggest Fixes to FDA's Adverse Event Database

    A team of researchers from Novartis, Oracle Health Sciences and the University of California, San Francisco say the US Food and Drug Administration's (FDA) adverse drug reaction database could be improved by grouping drugs by their chemical structure and automating certain reporting functions. In a paper appearing in eLife earlier this month, the researchers say such changes could help address several major challenges to interpreting data in FDA's adverse event reporti...
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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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    FDA Orders New Warnings on OTC Acetaminophen Drugs

    A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new statement warning consumers about the risk of the products causing serious skin reactions. Background The new guidance, Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions , follows a 2013 warning by FDA that ...
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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...
  • Feature ArticlesFeature Articles

    Leprosy––Not Yet Consigned to History

    The word leprosy brings to mind a gruesome disease that separates its sufferers from society and continues to strike fear into communities, much like Ebola. While the genome for leprosy has been sequenced and there is a drug cocktail that effectively cures the disease, its mode of transmission still is unknown. A disease that dates back through millennia, leprosy so far has eluded efforts to find the final piece of information that might eradicate it from the world per...
  • FDA Cracks Down on Spurious Marketing Claims for Cosmetic Products

    The US Food and Drug Administration (FDA) is increasingly cracking down on the marketing claims used by some cosmetic companies, firing off at least three warning letters in as many weeks regarding allegedly unfounded claims used to market various products. In an opening salvo, released in the form of an 11 September warning letter , FDA alleged French cosmetic giant L'Oreal's US subsidiary, Lancôme USA, was using a number of improper marketing claims that caused ...