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  • Data Reporting Mistake Hits Vertex Pharmaceuticals' Stock

    • 29 May 2012
    Hell hath no fury like a Wall Street analyst scorned. Or at least that's what Cambridge-based Vertex Pharmaceuticals might be thinking to itself today after admitting it had inadvertently overstated the effectiveness of its new combo therapy for cystic fibrosis (CF), causing shares of Vertex ( $VRTX ) to plummet. Vertex has been testing the new therapy, which consists of its already-approved drug Kalydeco (ivacaftor) and a new experimental compound known as VX 809. Unli...
  • UK Organizations Band Together to Form New Clinical Trial Transparency Standards

    • 24 May 2012
    A number of prominent UK healthcare organizations have banded together to form a new set of principles meant to set a new voluntary standard for the reporting of clinical trial data, reports PMLiVE . The coalition of groups, which includes the Association of the British Pharmaceutical Industry (ABPI), the General Medical Council, the Prescription Medicines Code of Practice Authority and The Academy of Medical Royal Colleges, is being called the Ethical Standards in He...
  • Warning Letter Analysis: Companies hit for CGMP, Reporting Violations

    • 17 May 2012
    The US Food and Drug Administration (FDA) released three warning letters on 17 May 2012 previously issued to companies in the healthcare product sector, including two pharmaceutical manufacturers and one blood products supplier detailing current Good Manufacturing Practices (cGMP) and adverse event reporting violations. Selder S.A. de C.V. (Pharmaceutical) A warning letter sent to Selder S.A.'s Director General and Owner, Alejandro Villarreal, by FDA identifies n...
  • Hamburg Calls for New Authority, Strengthened Anti-Counterfeit Laws

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said in a statement she believes existing pharmaceutical anti-counterfeiting laws are grossly inadequate to deter illicit activity, saying counterfeiters deserve "more severe consequences." Hamburg's 10 April statement on FDA Voice , FDA's blog, made clear she believes the Federal Food, Drug and Cosmetic Act (FD&C Act) is outdated. "[The FD&C Act ] was enacted in 1938, long before there was a...
  • Australian Adverse Event Database Hits Milestone

    Australia's Therapeutic Goods Administration (TGA) announced its adverse reactions database hit a milestone 4 April, logging a quarter of a million valid reports. The database, which has been running since 1971, is used by TGA to determine is regulatory action is necessary to protect the public from an already-approved product. "The TGA would like to thank all report contributors," the agency said in a statement. "Such information is vital to TGA efforts to promote the ...
  • FDA Seeks Feedback on Postmarketing Adverse Event Drug Reporting

    The US Food and Drug Administration (FDA) is looking for feedback regarding its postmarketing adverse drug experience reporting system, including ways to make the system more efficient and less burdensome for manufacturers. In a 20 March Federal Register posting, FDA said, "Information derived from the adverse drug experience reporting system contributes directly to increased public health protection because the information enables FDA to make important changes to the ...
  • Australia Launches Simplified Medical Device Adverse Event Reporting System

    Australia's Therapeutic Goods Administration (TGA) released a new online system for reporting adverse events (AEs) attributable to medical devices this week. In a 14 March press release, TGA noted that the system "consists of forms with easy-to-follow instructions for users and sponsors and manufacturers." Once the medical device AE report has been submitted, "any follow-up or final reports will still have to be submitted by email, fax or mail" until TGA is able to lau...
  • Study: Medical Device Safety Could Be Improved With Help of Software

    • 09 March 2012
    A new study published in the American Health Association's journal Circulation: Cardiovascular Quality and Outcomes says that commercially available software could discover problems with medical devices well before traditional adverse event tracking systems are able to, reports Fierce Health IT . The study looked at 2710 implantable cardioverter-defribrillator leads, of which 107 failed during the study. Software used by the study was able to successfully alert the au...
  • 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...
  • FDA Calls for Comments on Adverse Event Reporting for Medical Devices

    The US Food and Drug Administration (FDA) is calling for medical device manufacturers, importers and facility owners to provide feedback on how FDA collects information related to reports of serious adverse events-or potential events-related to medical devices. The collection of this information is currently mandated under §519(a)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act) , which says that "whenever the manufacturer or importer receives or othe...
  • 86% of Adverse Patient Events Go Unreported in Hospitals

    • 09 January 2012
    The US Department of Health and Human Services' (DHHS) Officer of the Inspector General (OIG) released a report on Friday, 6 January indicating that six in seven adverse events (AEs) that take place in hospitals go unreported. The OIG's Director, Daniel Levinson, noted that all hospitals being paid under Medicare are obligated to "track medical errors and adverse patient events, analyze their causes" and make improvements to reduce future incidence of AEs. Levinson fur...