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  • Regulatory NewsRegulatory News

    DTC Drug Ads: New Study Finds Perception of Risks Diluted by Lengthy Side Effects List

    A study on direct-to-consumer (DTC) drug advertising published Monday in Nature Human Behavior finds that consumers perceive drugs to be less risky when ads for the drug list all of its side effects compared to when only serious side effects are listed. "When commercials list severe side effects along with those that are most frequent…it dilutes consumers' judgements of the overall severity of the side effects," write authors Niro Sivanathan, associate professor of org...
  • Regulatory NewsRegulatory News

    Tufts CSDD Raises Questions over Adverse Event Reporting in US

    Inconsistencies in the way adverse event reports are filled out and sent to the US Food and Drug Administration (FDA) could mislead drug safety professionals and cause the wrong conclusions to be drawn, in addition to myriad other issues, according to a report from the Tufts Center for the Study of Drug Development released Wednesday. Background FDA has three adverse event reporting forms it uses to collect data on drugs (prescription and non-prescription), biologics, m...
  • Regulatory NewsRegulatory News

    FDA and Google Talk 'Adverse Event Trending'

    Last month, representatives from the US Food and Drug Administration (FDA) and search giant Google met to discuss "adverse event trending," Bloomberg reports. Background Currently, FDA keeps track of adverse events submitted through voluntary and mandatory reports to its FDA Adverse Event Reporting System (FAERS). Drugmakers are required to report adverse events to the agency; however, patients and their doctors do so voluntarily, leading to serious underreporting. ...
  • Regulatory NewsRegulatory News

    FDA Explains how Companies can Modify a Drug Safety Assurance Plan

    A new guidance document issued by the US Food and Drug Administration (FDA) explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs. Background The policies, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007 Food and Drug Administration Amendments Act (FDAAA) and are meant to ensure the safe use of potentially risk...
  • Feature ArticlesFeature Articles

    Sleep—Still a Mystery!

    • 07 May 2014
    Most people spend a full third of their lives asleep, yet most of us do not have the faintest idea what sleep does to our bodies and our brains. Sleep remains one of the secrets of science. 1 However, there is ample evidence indicating that difficulty in falling asleep and non-restorative sleep are associated with the risk of cardiovascular disease in adults and young children. Statistically, after adjusting for lifestyle factors, age and chronic conditions, researchers ...
  • FDA Plans Multi-Year Investigation Into Rare Side-Effect of Heparin

    The US Food and Drug Administration (FDA) has announced that it will give researchers a quarter of a million dollars to help identify the source of a major safety risk now affecting heparin products. Heparin, a mixture of non-standard-length polysaccharides, acts as an anticoagulant under normal circumstances. However, a notable side effect known as heparin-induced thrombocytopenia (HIT) results in a decrease of platelets in the blood resulting in the release of abnormal...
  • Congressional Research Service Releases Side-by-side Analysis of User Fee Bills

    • 01 June 2012
    The Congressional Research Service, the House and Senate's semi-private think tank, has released what it is calling a side-by-side comparison of the Senate's Food and Drug Administration Safety and Innovation Act (FDASIA) and the House's Food and Drug Administration Reform Act (FDARA) . The report contains brief summaries of both bills' titles and provisions and how they relate to and alter current laws, particularly the Federal Food, Drug and Cosmetic Act (FD&C ...
  • New EMA-Run Website Looks to Boost Adverse Event Reporting Transparency

    The European Medicines Agency (EMA) is looking to enhance its transparency measures surrounding the receipt and publication of adverse event reports for all medicines authorized in the European Economic Area (EEA) through a brand-new website. The website, www.ADRreports.eu , is linked up with EMA's EudraVigilance adverse event reporting database and already contains information on more than 650 medicines authorized through the centralized procedure. Each report on the w...
  • Study: Patients Often Unaware of Off-Label Prescribing Risks

    A study of 150 European patient groups conducted on behalf of the Irish Patients Association (IPA) has found that patients are usually not made aware that the medication they have been prescribed is off label or how to respond to off-label side effects, reports The Pharma Times . Sixty-six percent of groups polled said that their patients were not always aware that the prescribed drug product was off-label, while 12% said that none of their patients were ever aware if t...
  • FDA Releases Warning About Mixing Grapefruit Juice, Medicines

    The US Food and Drug Administration wants you to know that grapefruit juice is great for you-except when it isn't. The agency sent out a press release to consumers on 22 February warning them that taking the fruity drink along with medication can cause dangerous side effects. The "juice increases the absorption of [a] drug into the blood steam," warned Shiew Mei Huang, acting director of FDA's Office of Clinical Pharmacology. This can cause adverse events by causing hi...