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    Australian TGA Taking a More Discerning Approach to Notified Bodies

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits  for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessments from several Notified Bodies. The TGA move could cause delayed Australian market entry for manufacturers that have used the...
  • Diabetes Drugs Taken by Millions May be Less Safe than Currently Believed, Reports BMJ

    A class of diabetes drug taken by millions of patients around the world may be considerably more dangerous than originally though, owing to the reticence of pharmaceutical companies to share data and make public the results of some of their studies, claim investigators with the British Medical Journal . Background The class of drugs, known as glucagon-like peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors, have already been the subject of ongoing ...
  • Medical Journal Calls for National Approach to Canadian Drug Shortage Crisis

    Pharmacists and patients in Canada are experiencing frequent drug shortages as the result of numerous and complex factors, leading the Canadian Medical Association Journal (CMAJ) to call for a national approach to managing the crisis . Writing in the 20 August edition of CMAJ , Dr. Matthew Stanbrook, deputy editor of CMAJ and Rosemary Killeen, editor-in-chief of the Canadian Pharmacists Journal , explained the shortages are increasing in severity and scope, result...
  • Researchers: Have Clinical Trial Regulation Progressed too Quickly in Developing Nations?

    • 15 June 2012
    "Two steps forward, one step back," laments an old proverb, describing the all-too-common tendency of progress to come paired with unexpected setbacks. Take, for instance, clinical trials regulations in emerging countries, write two researchers in the 12 June issue of the open source medical journal The Public Library of Science: Medicine (PLoS:M) . Many of the countries once lacked any semblance of a regulatory system, leaving trials to exist in a regulatory vacuum-if ...
  • FDA Calls out Pharma Company for Repeated 'Violative' Marketing Practices

    The US Food and Drug Administration (FDA) released a warning letter sent to Octapharma USA, Inc on 10 April 2012, in which the agency scolds the company for numerous marketing violations. FDA's Advertising and Promotional Labeling Branch (APLB), located within the Center for Biologics Research and Evaluation, reviewed some of Octapharma's advertisements within two publications released in December 2011. FDA rapped Octapharma for "false and misleading" advertisements aft...
  • After Regulatory Issues Raised, Medtronic Plans to Heighten Postmarketing Safety Monitoring

    After a string of "headline-grabbing" recalls involving medical devices in recent months, Minneapolis-based medical device manufacturer Medtronic is announcing its intent to increase its postmarketing safety surveillance of its implantable products, reports Reuters . "The US Food and Drug Administration (FDA) alone does not have the infrastructure," said Medtronic CEO Omar Ishrak in an interview with Reuters , "so companies have to play a leading role in this." "We ne...
  • Report: Postmarketing Regulatory Troubles at St. Jude Depress Share Value

    The regulatory issues faced by St. Jude as a result of unfavorable reports concerning the safety of its Riata defibrillator leads-as well as the company's cessation of sales for its Quicksite and QuickFlex defibrillator leads-are causing more than just publicity problems for the company, reports Reuters . The regulatory issues are "raising concerns on Wall Street that doctors will curb use of the company's products, weakening its position in the $6.5 billion global mark...
  • EMA Looks to Open Up Clinical Trial Data After Concerns About Tamiflu Raised

    The European Medicines Agency (EMA) announced it is looking to develop a "way forward for publication of full clinical trial data" after concerns were published about selective publication of Tamiflu efficacy data. Tamiflu, which was stockpiled heavily around 2009 due to fears about swine flu, was recently attacked in the medical journal PLoS Medicine by authors Peter Doshi, Tom Jefferson and Chris Del Mar, who claim the drug overstated its effectiveness by hiding cert...
  • As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

    A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude's requests to retract an article implying defibrillator leads on St. Jude's Riata products were less safe than previously known, reports various sources. St. Jude had previously released a press release on 6 April calling on the journal to retract the article in light of what it said were "numerous mistakes and oversights," repo...
  • Study: Poor Health Literacy Detrimental to Patient Health Outcomes

    A new study in the British Medical Journal has found that limited health literacy was associated with higher rates of death among study participants. The study tracked nearly 8,000 patients over the age of 52, and sought to understand the effects of health literacy on patient health. To do this, the study asked patients to read the label of a medicine bottle and answer four simple questions, such as the maximum number of days a medicine may be taken and situations req...
  • Researchers: Metal-on-Metal Hips Implants Should be Banned

    Researchers working with the world's largest database on hip replacements have found so-called metal-on-metal hip implants are associated with high rates of failure, and recommended that they not be implanted in patients going forward. Writing for the journal The Lancet , the researchers found that more than half a million US patients and 40,000 UK patients are implanted with the devices and subject to a higher risk of device failure than those patients with non-metal h...
  • Australia's Regulatory Body Takes Fire Over Medical Device Testing

    Australia's Therapeutic Goods Administration (TGA) is taking fire from the Medical Journal of Australia (MJA) for a lack of medical device safety oversight, reports Fierce Medical Devices . MJA wrote 5 March that "[t]here is minimal systematized collection of data about devices in clinical use that could supply relevant demographic data about patients using the drug or device, or data about the effectiveness and safety of the device in clinical practice." MJA a...