• Regulatory NewsRegulatory News

    California Governor Vetoes Right-to-Try Bill, Points to FDA Compassionate Use Program

    California Gov. Jerry Brown (D) on Sunday vetoed a bill that would've allowed a pharmaceutical company to make an investigational drug available to a patient with a terminal illness on the recommendation of two physicians. Brown explained in a message with his decision that the so-called "Right to Try" (RTT) legislation is intended to help patients with life-threatening conditions, and in some cases these patients can already gain access to experimental treatments under ...
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    European Commission Seeks Industry Comment on New GMP Guidelines for Investigational Drugs

    The European Commission is seeking comment from industry on two documents tied to the guidelines and principles of good manufacturing practices (GMP) for investigational drugs. The commission notes that the current GMPs for medicinal products for human use from a 2003 directive are "generally well-functioning," so, "There is no need to reinvent the wheel." The application of GMPs for investigational drugs is intended to ensure that clinical trial subjects are not p...
  • MHRA Wants Input on Single-Use Device Re-Manufacture Guidance

    The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices. Note: at the time of publishing, the survey appears to be closed. According to MHRA's announcement the survey should be available until 1 September 2015. Background In the past, medical devices were typically designed to be reusable and were built to withstand cleaning procedures such...
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    'Right to Try' Legislation Tracker

    Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as " Compassionate Use ," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies. This Right to Try Legislation Tracker is meant to be a resource for...
  • Feature ArticlesFeature Articles

    Health Canada to Regulate Reprocessors of Single Use Medical Devices as Manufacturers

    This article explains reasons for reprocessing Single Use Devices (SUDs), major concerns about this practice and the potential impact of these new requirements. For the past several years, the Canadian medical devices industry has opposed reprocessing SUDs strongly, mainly because of unknown safety procedures, although this practice commonly is used in hospitals and by third-party service companies. The Reuse of Single Use Devices Task Force within Canada's medical tec...
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    FDA Seeking Safer Medical Devices Through eLabeling Pilot

    Medical devices used in home healthcare settings may soon be made safer thanks to a labeling program being piloted by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). Background In general, medical devices can be divided into two categories: those intended to be used in professional settings by healthcare professionals, and those intended to be used in home healthcare settings by patients or caregivers. The latter category,...
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    In Fight Against Ebola, Device Company Seeks FDA Approval Through Rarely Used Pathway

    In the battle against the Ebola virus, perhaps no weapons have been as sought after as new treatments and diagnostic products to help keep the virus in check and patients safe from harm. But since the start of the outbreak in 2014, one regulatory standard has been an elusive goal for these medical products: Approval. To date, no product has received the full approval of the US Food and Drug Administration (FDA). Now one company is hoping to change that. Seeking Approval ...
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    EU Committee Wants Additional Restrictions on Codeine Use in Children

    A European committee is recommending a series of restrictions on the use of medicines containing codeine in children. PRAC’s Recommendations Citing concerns that codeine can cause breathing problems and other serious adverse effects in children, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is recommending codeine be contraindicated for children less than 12 years of age. Additionally, PRAC says that children between ages 12 ...
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    An Argument for Emergency Authorization During Public Health Crises

    When a public health crisis like Ebola emerges, public health officials need the flexibility to respond quickly and effectively. But as a new paper in the journal Public Library of Science - Medicine (PLoS Medicine) argues, many countries currently have in place regulatory hurdles which would delay access to experimental new emergency treatments during such crises. Background Many global healthcare product regulators have in place provisions designed to speed ac...
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    Facing Enterovirus Outbreak, HHS Gives FDA Power to Authorize Use of Experimental Diagnostics

    The US Department of Health and Human Services (DHHS) has declared that a strain of enterovirus now sweeping across the US has a high potential to cause a "public health emergency," thereby allowing the US Food and Drug Administration (FDA) to clear the use of drugs and diagnostic devices under special "emergency use" regulatory pathways. According to the US Centers for Disease Control and Prevention (CDC), the virus, known as enterovirus D68, is one of more than 100 n...
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    WHO Gives OK to First Rapid-Result Ebola Diagnostic

    The World Health Organization (WHO) has approved the first rapid-result diagnostic test for detecting Ebola. The product, known as ReEBOV Antigen Rapid Test, can help health care workers quickly confirm suspected cases of Ebola. Despite international efforts, Ebola has caused more than 9,400 deaths in West Africa since the outbreak began in March 2014. Rapid Results ReEBOV has a number of advantages over other diagnostics. The product is simple to u...
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    New Health Canada Rules Cover Single-Use Reprocessed Devices

    Content provided by  Emergo , a medical deviceregulatory affairs and quality assurance consulting firm with offices worldwide. Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to follow Canadian Medical Device Regulations (CMDR) by 1 September 2016. According to Canadian medical technology trade group MEDEC, the new  requirement  will apply to all commercially reprocessed single-use devices, but...