• Regulatory NewsRegulatory News

    USP, NIST and NIIMBL collaborate to boost viral vector quality standards

    A new public-private collaborative among the United States Pharmacopeia (USP), the US Department of Commerce’s National Institute of Standards and Technology (NIST) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) pools the expertise or the organizations to develop better measurement tools to assess the quality of adeno-associated virus (AAV), an increasingly important vector for gene therapy delivery.   According to a 27 June ann...
  • Regulatory NewsRegulatory News

    NIST Kicks Off Wireless Infusion Pump Cybersecurity Project

    The National Institute of Standards and Technology (NIST) is launching a project to improve the cybersecurity of wireless infusion pumps. To do so, NIST's National Cybersecurity Center of Excellence (NCCoE) is looking for vendors to provide it with the components and technical expertise required to simulate the hospital environment in which infusion pumps operate. In a notice published in the Federal Register Monday, NIST said the goal of the project is to help health...
  • Federal Board: Need for a Single Entity to Assess Cybersecurity Standards for Devices

    A federal information security board is weighing in on a recent medical device cybersecurity guidance document published by the US Food and Drug Administration (FDA), stating that it is troubling that no one single federal entity is responsible for the cybersecurity of medical devices-an oversight that could cause harm to patients. Background The board in question is the Information Security and Privacy Board (ISPAB), a little-known entity first established by the Compu...
  • Standards Board Warns of Potential Device Hacking, Calls for Increased FDA Authority

    A board convened by the National Institute of Standards and Technology is warning the US Food and Drug Administration (FDA) about their concern for medical device safety in the wake of mounting security concerns about hacking, reports Wired and Medical Daily . The group is calling for FDA-or another similar entity, if need be-to be granted the authority to assess the security of devices before being brought to market, as well as the establishment of a postmarketing su...