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  • Regulatory NewsRegulatory News

    Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices

    A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death. The analysis, published in Nature Biomedical Engineering on Friday, raises questions about the trade-offs between speeding access to new devices and ensuring their safety. Specifically, the authors looked at the number of adverse events reported to the ...
  • For First Time Since Founding, Government's Mini-Sentinel System Shrinks in Size

    The US government's Mini-Sentinel adverse event active surveillance system had something unusual happen to it this year: It shrank. Background Mini-Sentinel was created in 2008 as an effort to create a nationwide system to track products regulated by FDA after their approval. With the  Food and Drug Administration Amendments Act (FDAAA)  placing a far greater emphasis on post-approval requirements for drugs (instead of requiring all data to be submitted prio...
  • Brazil Launches New Adverse Event Reporting System

    Brazilian officials are launching an online system for health professionals to report serious or fatal accidents involving defective products or services, including healthcare products.  Health professionals will log adverse events involving drugs, devices, toys, cosmetics and food into a new Consumer Accidents Information System (SIAC) database, initially on a voluntary basis. Reporting will eventually be mandatory. Top of Form The Municipal Hospital of Cuiab&aacu...
  • GHTF Releases Guidance on Adverse Event Data Reporting Standard

    The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final guidance document on its N54:2006 adverse event data reporting standard. The non-binding guidance document, N87: An XML Schema for the electronic transfer of adverse event data between manufacturers, authorised representatives and National Competent Authorities (NCAs) , wa...
  • 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...
  • FDA 'Aghast' at Lack of cGMP, AER Compliance by Supplement Manufacturers

    The US Food and Drug Administration's (FDA) top dietary supplement regulator said at an industry conference meeting he is " aghast at the degree of non-compliance " when it comes to current good manufacturing practices (cGMPs) and adverse event reporting (AER) in the industry, reports Nutra Ingredients USA . Speaking 25 April to a meeting convened by the Natural Products Association, Daniel Fabricant, director of FDA's Dvision of Dietary Supplement Programs, said the in...
  • 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...
  • FDA Releases Guidance on Reporting Adverse Events During Flu Pandemic

    The US Food and Drug Administration (FDA) released a final guidance on 24 February that deals with how it intends to enforce adverse event reporting (AER) requirements if-or when-an influenza pandemic occurs. FDA notes that during a pandemic  it anticipates that its resources-and those of some manufactures-will be deployed most prominently to deal with that particular public health issue. This is problematic, as the amount of products being used to combat influen...