• EC Committees: Changes Coming to European Human Risk Assessment

    • 22 October 2012
    A new discussion paper generated by three of the EU's top scientific committee has called for a paradigm shift in the way regulators assess risks to human health from a hazard-driven process to one driven by exposure. The paper, Addressing the New Challenges for Risk Assessment , was issued by three of the European Commission's Scientific Committees: the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), the Scientific Committee on Consumer ...
  • Feature ArticlesFeature Articles

    Establishing Effective Device Supplier Qualifications

    Supplier qualification is an important quality system requirement that, when performed effectively, ensures with a high level of confidence that a purchased product will consistently meet specified requirements. An effective supplier qualification procedure should include risk analysis, quality auditing and the use of qualified analytical test methods and statistical techniques to determine supplier capability. A risk score assigned to suppliers, based on the result of s...
  • Government Investigators: FDA Must Assess Medical Devices for Hacking Risks

    Government oversight officials are sounding the alarm over what they say is the potential for US Food and Drug Administration-regulated medical devices to be hacked, saying FDA needs to establish new safeguards to ensure unguarded devices don't exhibit easily exploited vulnerabilities. The report, " FDA Should Expand Its Consideration of Information Security for Certain Types of Devices ," was authored by the Government Accountability Office (GAO), an investigative servi...
  • New Draft European HTA Guidelines Released

    The EU health technology assessment network (EUnetHTA) has released for public comment five draft European methodology guidelines for relative effectiveness assessment of pharmaceuticals: Guideline on direct and indirect comparisons   Guideline on clinical endpoints Guideline on Health related quality of life (HRQoL) Guideline on safety Guideline on internal validity The primary objective of these guidelines is to assist national HTA assessors in E...
  • European Commission: Consultation on Stakeholder Participation In HTA Network

    The European Commission is  requesting input  from stakeholders, including drug and device companies, as to "how the consultation with stakeholders in the Health Technology Assessment (HTA) network's activities could be facilitated."  An "informal" HTA network of member state entities that conduct relative effectiveness work-such as the UK's NICE and Germany's IQWiG-was mandated in 2011 "to support collaboration between Member States in developing and sha...
  • EC: SCENIHR Issues Memorandum on Europe's Scientific Risk Assessment Process

    A memorandum issued by the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is intended to provide transparency to stakeholders on the Committee risk assessment process.  Risk assessments inevitably involve human scientific judgments and there are stressors to which humans may be exposed. The memorandum is intended to complement the draft SCENIHR report on the identification of emerging issues and the work of SCE...
  • FDA Creates Program to Boost Regulatory Science, Speed Drug Development

    The US Food and Drug Administration (FDA) is announcing the launch of a new program that it hopes will help to advance clinical trial design and endpoints to boost regulatory science and facilitate expedited drug development. The program, which FDA is calling the Drug Development Tools (DDTs) Qualification Program, is being run by FDA's Center for Drug Evaluation and Research (CDER). The Center sees the program as "a mechanism for formal review by CDER to qualify drug de...