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    FDA Finalizes Two Guidances on Sharing Device Data With Patients, Aspirator Device Labeling

    The US Food and Drug Administration (FDA) on Friday finalized two guidance documents, including one related to medical device manufacturers sharing information with patients upon request, and another to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices. Sharing Patient Info The five-page guidance, first released as a draft in June 2016 , is meant to convey FDA's position on manufacturers ...
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    Cybersecurity: House Committee Looks to Build on Public-Private Partnerships

    The House Energy & Commerce Committee on Tuesday held a hearing looking into ways to improve cybersecurity across the healthcare sector. In recent years, cybersecurity has been a growing concern in healthcare, with high profile cyber-attacks and vulnerabilities causing disruptions for insurers , hospitals and medical device makers . The stakes for patients are high too as patient data could be lost or tampered with, hospital services interrupted or patients harmed t...
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    EMA Official: Data Sharing and Collaboration Can Fill Scientific Gaps in Alzheimer's

    Speaking at a panel at RAPS' 2016 Convergence on Monday, Enrica Alteri, head of human medicines research and development support at the European Medicines Agency (EMA) called on drugmakers to share data to close the gaps in Alzheimer's disease (AD) research. According to Alteri, doing so could help the scientific community not only learn from past failures in Alzheimer's research, but enable the development and validation of new targets. Scientific Gaps "There are gaps...
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    Industry, Patient Groups Respond to FDA Guidance on Sharing Patient-Specific Device Data

    Several groups representing the medical device industry and patients are calling for more clarity from the US Food and Drug Administration (FDA) on its recent draft guidance on sharing patient-specific device data with patients. In June, FDA released its draft guidance, Dissemination of Patient-Specific Information From Devices by Device Manufacturers , to clarify that device makers may share patient-specific information recorded, stored, processed, retrieved and/or d...
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    FDA, Health Canada Look to Implement Common Electronic Submission System

    As part of efforts to further align the US Food and Drug Administration (FDA) and Health Canada, both sides are working to implement a common electronic submission gateway to allow pharmaceutical companies to submit large electronic documents simultaneously to both regulators. The collaborative effort is just one of a number of joint action plans the two sides are planning as part of the Canada-US Regulatory Cooperation Council (RCC), which aims to increase collaboratio...
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    FDA Offers New Draft Guidance on How Device Manufacturers Can Share Data With Patients

    As patients increasingly play a more active role in their own healthcare, the US Food and Drug Administration (FDA) on Thursday issued new draft guidance to clarify that medical device manufacturers may share patient-specific information recorded, stored, processed, retrieved and/or derived from a device that helps to treat or diagnose that patient. The draft guidance outlines considerations for the form in which this device data – which can include usage statistics (pul...
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    Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development

    Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive Safety Testing Consortium (PSTC) workshop at the US Food and Drug Administration's (FDA) White Oak campus on Monday said. Biomarkers are biological characteristics that can be measured to give an indication of a biological process or the presence or likelihood of a disease.  They can also predict how a patient might respond to a particular inter...
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    Questions Remain on How Device Cybersecurity Data Sharing Will Work

    A key component in the US Food and Drug Administration's (FDA) postmarket guidance for medical device cybersecurity is participation in Information sharing analysis organizations (ISAOs), though questions remain about how these organizations will function and be governed. In February 2015, President Obama, through Executive Order 13691 , encouraged the development of ISAOs across various sectors for stakeholders "to share information related to cybersecurity risks and i...
  • US, Mexico Announce Plan to Strengthen Regulatory Cooperation

    US Health and Human Services Secretary Kathleen Sebelius and Mexico's Secretary of Health Salomón Chertorivski jointly announced the launch of a new program aimed at increasing regulatory cooperation at a meeting in Geneva, Switzerland on 22 May. Sebelius and Chertorivski were at the 65 th World Health Assembly, where both acknowledged their mutual goals in promoting public health. "It is important to strengthen the programs of regulation and surveillance of med...
  • Bill Would Restrict Co-Pays, Other Cost-Sharing Measures

    • 20 March 2012
    Co-pays, cost-sharing, coinsurance and other methods used by pharmaceutical companies as an incentive for patients to purchase their drugs would be restricted under a new bipartisan bill introduced in the House of Representatives on 19 March. H.R. 4209 - Patient's Access to Treatments Act of 2012 , introduced by Reps. David McKinley (R-WV), Lois Capps (D-CA), Barney Frank (D-MA), Henry Cuellar (D-TX) and C.W. Bill Young (R-FL), would do away with preferential treatmen...