• Feature ArticlesFeature Articles

    Perspective: Advancing Breakthrough Therapies for Patients

    Advances in science and medicine are leading to exciting possibilities for the treatment of serious or life-threatening conditions, such as cancer. Growing knowledge of disease biology and molecular targets has shifted drug development from a traditional "shotgun" approach to targeted, precision medicines. Understanding the biological basis and natural history of a complex disease, such as cancer, unlocks the potential for new treatment options. In particular, novel-nov...
  • New Provisions in Senate User Fee Bill as Vote Scheduled

    • 17 May 2012
    The Senate is scheduled to take up the Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) on Thursday, 17 May, and numerous sources report new provisions have entered into the latest iteration of the legislation. The bill, which contains several pieces of related legislation, is intended to reauthorize industry-funded user fees for pharmaceutical and medical device products and make a host of changes to FDA's regulatory processes. Both Politico an...
  • FDA Plans Meeting to Explore Ways to Involve Patient Advocacy Groups in Regulatory Decision-making

    The US Food and Drug Administration is announcing its intent to hold a meeting on how best to involve patients, patient advocacy groups and health professional groups in regulatory decision-making. The meeting, FDA's first Patient Network program Annual Meeting entitled "Input into FDA Benefit-Risk decision-making: Opportunities and Challenges," is being hosted by FDA's Office of Special Health Issues and will be held on 18 May 2012. FDA said in a statement, "the meetin...
  • Legislation to Make FDA's Regulatory Calculus More Transparent Introduced in Congress

    Sens. Richard Burr (R-NC) and Tom Coburn (R-OK) introduced legislation that would reform the US Food and Drug Administration's (FDA) regulatory transparency by mandating the agency submit to Congress the scientific and regulatory calculus behind pharmaceutical and medical device submission decisions. Sens. Burr and Coburn said their bill, the Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA (PATIENTS' FDA) Act , is "designed to...
  • FDA Plans Study on How Obese Patients Make Decisions, Perceive Risk

    The US Food and Drug Administration (FDA) announced it is looking to conduct a study probing how patients perceive risk and come to make decisions, particularly in the context of obese patients seeking medical interventions to reduce their weight. FDA notes in its 18 April Federal Register posting that a whopping 35.5% of men and 35.8% of women in the US are reportedly obese-increasing from 25.7% and 27%, respectively, in 2000. Understanding how this demographic makes...
  • Bill Would Address Medical Device Safety By Giving FDA Additional Authority

    A new bill introduced in the Senate would address medical device safety by giving the US Food and Drug Administration (FDA) additional authority to conduct postmarketing surveillance. "Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market," said Senator Jeff Merkley, the bill's chief sponso...
  • Japan Looks to Overhaul Compassionate Use Regulations

    The Japanese government is taking steps toward overhauling regulatory provisions that would allow seriously ill patients to access unapproved products under 'compassionate use' provisions , reports Reuters . "Japan is considering allowing the use of drugs and medical devices that have already been approved in places such as the United States and Europe and which are undergoing clinical trials in Japan," said Toshio Miyata, assistant director at the licensing division o...
  • Study: Patients Often Unaware of Off-Label Prescribing Risks

    A study of 150 European patient groups conducted on behalf of the Irish Patients Association (IPA) has found that patients are usually not made aware that the medication they have been prescribed is off label or how to respond to off-label side effects, reports The Pharma Times . Sixty-six percent of groups polled said that their patients were not always aware that the prescribed drug product was off-label, while 12% said that none of their patients were ever aware if t...
  • MHRA: Patients With Metal-on-Metal Hips Need Extensive Monitoring

    The Medicines and Healthcare products Regulatory Agency (MHRA) issued advice to patients and surgeons urging them to monitor so-called metal-on-metal hip replacements on an annual basis for the lifetime of the device. Previous advice by MHRA has only advised patients and surgeons to monitor the device for 5 years after the device was implanted. "This updated advice is based on updated evidence that patients with hip replacements with head diameter of 36 millimetres or...
  • NIH Releases New Clinical Trials Research Website

    • 07 February 2012
    The National Institutes of Health (NIH) released a new website on 6 February called NIH Clinical Research Trials and You that aims to educate the public about clinical trials and how to participate in them. "Clinical trials are essential for identifying and understanding ways to prevent, diagnose, and treat disease," said NIH in a press release . "Research has shown that among the greatest challenges to recruitment of volunteers is the lack of general knowledge abou...