• After Flu Concerns, Regulators Look to Issue Guidelines on 'Dual Use' Preclinical Studies

    International healthcare bodies are looking to issue guidelines on 'dual use' research on potentially hazardous materials and diseases after a researcher sent shockwaves through the medical community in 2012 for his re-engineering research on a potentially deadly strain of bird flu, reports The Financial Times. "Washington has just issued new guidelines; the Royal Society, the British scientific organization, rushed to convene a high-level session last week on the topi...
  • 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...
  • 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...