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  • 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...
  • Study Finds Widespread Problems in Reporting of Clinical Trial Results

    According to a new study published in the Journal of the American Medical Association (JAMA) , the results of clinical trials reported to the public are frequently inaccurate, raising questions about the accuracy of current and future trial transparency efforts. The study, Reporting of Results in ClinicalTrials.gov and High-Impact Journals , looked at 96 different research trial results published in prestigious medical journals (impact factor greater than or equal to 1...
  • 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...
  • Could FDA's New Drug Shortage Rule Make Shortages Worse? Generic Drug Industry Says 'Yes'

    The US' generic pharmaceutical manufacturing industry is taking issue with one of the core components of a new drug shortage strategy laid out by the US Food and Drug Administration (FDA), calling it well-intentioned but infeasible and even harmful in some cases. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injectable drugs experiencing supply shortages. Investigations into the matter brought to light a number of reasons...
  • FDA Proposes Making Antibiotic Monitoring Report More Useful

    Nearly five years after the passage of the Animal Drug User Fee Amendments Act (ADUFA) of 2008, the US Food and Drug Administration (FDA) is proposing to expand upon its data reporting requirements, saying companies will need to include even more data on the antimicrobial drugs they sell for use in food-producing animals. Background The policy is being advanced through proposed rulemaking released on 26 September 2013 by the agency. It was first released as a propose...
  • Australia’s TGA Launches Database of Adverse Event Notifications

    Australia's Therapeutic Goods Administration has launched a new Database of Adverse Event Notifications (DAEN), an online resource that will provide the public and the health care community with access to adverse event reports. The database, which will be updated monthly, includes reports from January 1971 up until three months prior to the date of access to allow the agency to investigate new reports.   The database currently contains around 251,000 reports...
  • Legislation would Create New Incentives, Penalties to Compel Reporting of Trials Results

    • 10 June 2013
    A new piece of legislation introduced in the US House of Representatives last week would require clinical trials to report their results to an existing registry maintained by US officials or risk losing both current and future funding. Background At present, sponsors of clinical trials are responsible for making basic data available to the public through a database maintained by the US Food and Drug Administration ( FDA ) and the National Institutes of Health (NIH) know...
  • New Medwatch Form Geared Toward Simple Adverse Event Reporting for Consumers

    The US Food and Drug Administration (FDA) is touting the 20 th anniversary of one of its most essential safety reporting tools, MedWatch, which it uses to collect adverse event reports about pharmaceuticals, medical devices and other FDA-regulated products, allowing it to monitor risks to consumers and take action when necessary. And now FDA is announcing something else: a consumer-focused MedWatch reporting form. Background In a 3 June 2013 posting on FDA's Voice bl...
  • Pfizer Subsidiary Hit with Warning Letter for CGMP, Reporting Problems

    A warning letter sent to an Italian subsidiary of Pfizer, Wyeth Lederle S.p.A., by the US Food and Drug Administration (FDA) claims that the company's Catania, Italy manufacturing facility has significant manufacturing and reporting deficiencies which may prevent the company's products from entering into the US. CGMP Issues The letter references a July 2012 inspection of the Catania plant where FDA inspectors say they found unexplained discrepancies that went uninvestig...
  • Amended EU Clinical Trials Proposal Calls for Full Publication of Clinical Trials Data

    A newly-amended draft report published by the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) seeks to advance a proposal that would overhaul the EU's clinical trials regulatory framework by repealing Directive 2001/20/EC and replacing it with a new regulation.  [ Editor's note: a previous version said it would be replaced with a new Directive. It is instead being replaced with a new regulation. ] The 55-page draft include...
  • OIG Report Details Scope of Fines Levied on Pharmaceutical Manufacturers in 2012

    • 29 November 2012
    The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), the office charged with investigating potential legal violations and recovering funds for taxpayers, has had a busy year. In a report submitted to Congress this week detailing the agency's actions for the second half of the fiscal year (April through September), Inspector General Daniel Levinson said his agency had recovered just shy of $7 billion for taxpayers-nearly three ti...
  • Sunshine Act Clears CMS Review, But Final Promulgation Could be Months Off

    • 29 November 2012
    Signs are emerging that a long-awaited landmark regulation governing the transparency of gifts given to medical practitioners by industry has entered its last clearance stage before final promulgation. The rule, Transparency Reports and Reporting of Physician Ownership of Investment Interests , is the direct result of the Patient Protection and Affordable Care Act (PPACA) -colloquially known as Obamacare-the seventh title of which contains the "Physicians Payment Suns...