• 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...
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    FDA Launches Big Data 'openFDA' Initiative, Giving Public Easier Access to Safety Information

    The US Food and Drug Administration (FDA) has launched a long-awaited technology initiative intended to free regulatory data that was once difficult to obtain and harder still to make sense of. Background The initiative, known as openFDA, comes in the wake of a May 2012 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....
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    FDA Launching Pilot Program to Assess Vaccine Safety Reporting Capabilities

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is launching a pilot program intended to assess its capacity to receive reports of adverse events related to the use of vaccines. At present, CBER—working in tandem with the Centers for Disease Control and Prevention (CDC)—receives vaccine-related adverse events electronically through its Vaccine Adverse Event Reporting System (VAERS), which accepts the International Conferenc...
  • 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...
  • 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,...
  • 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...
  • FDA Makes it Easier to Report Safety Problems Associated with Dietary Supplements

    Manufacturers and sponsors of dietary supplement products in the US will now have a new, more streamlined method of reporting adverse events to the US Food and Drug Administration (FDA), officials said today. In a 13 January 2014 announcement , FDA's Center for Food Safety and Applied Nutrition (CFSAN) wrote that the agency is now accepting online submission of voluntary and mandatory supplement adverse event reports. Previously, Forms FDA-3500 and -3500A, the forms u...
  • Anvisa Unveils New Adverse Event Database

    Brazil's national regulatory agency, Anvisa, has unveiled a new database that will gather information on adverse events relating to blood products, tissues, cells and organs.  The database, which was developed by Italy's National Transplant Center, already includes more than 900 adverse event reports related to cell therapies, organ donations, and assisted reproduction, among others.  The database was first unveiled at the World Health Organization's (WHO)...
  • EU Regulators Launch Vaccine-Focused Pharmacovigilance Project

    EU pharmacovigilance is expanding in a big way for vaccine products, the European Medicines Agency (EMA) has announced. Under a new plan unveiled on 26 November 2013, EMA will be working with other regulatory bodies on a new five-year project known as the Accelerated Development of Vaccine Benefit-Risk Collaboration in Europe ( ADVANCE ), the intent of which is to better assess the risks and benefits of a vaccine throughout its lifecycle. Unlike many drugs, vaccines are...
  • TGA Adopts Internationally-Recognized E2B Reporting System

    Australia's Therapeutic Goods Administration (TGA) has adopted a "streamlined" way for sponsors to submit  adverse event reports  for medicines and vaccines, aligning TGA's system with the European Union, the US, Japan and Canada. Sponsors are now able to submit adverse event reports by email ( e2b.reports@tga.gov.au ) using the international E2B standard, supported by the International Conference on Harmonization (ICH). Data supplied in this format can be ent...
  • India’s Health Ministry Acts on CDSCO Reform Recommendations

    India's Ministry of Health and Family Welfare (MHFW) has issued a report recommending the implementation of several reforms to the country's drug approval and clinical trials system. The reforms had originally been submitted to the Ministry by an Expert Committee chaired by Prof. Ranjit Roy Chaudhury, created in response to the Parliamentary Standing Committee on Health and Family Welfare's critical 59th Report on the functioning of India's Central Drugs Standard Contr...
  • Citing Funding Woes, FDA Cancels Adverse Event Safety Mining Project

    Funding woes have caused the US Food and Drug Administration (FDA) to cancel a proposed project that would have seen it mining drug adverse event safety signals from literature reports. Background FDA regularly puts out requests for proposals and solicitations on the Federal Business Opportunities (FBO) website, and lately has expressed a keen interest in methods of monitoring adverse event data. In April 2013, for example, it put out a notice indicating it wants a par...