• Feature ArticlesFeature Articles

    The Need for More Certainty in Reimbursement Strategies

    Integrating Health Outcome Parameters with Clinical Development For drug developers, getting a treatment to market with regulatory approval is proving to be only half the battle. Once in Phase 4, applying for reimbursement approval prompts an entirely new process, which can differ considerably from regulatory approval in terms of the health outcomes and evidence parameters that are evaluated. Regulatory approval, once considered the gold standard, is no longer good eno...
  • EU: New European Healthcare Advisory Panel Formed

    The European Commission adopted a Decision on 6 July to establish an independent expert panel to advise the Commission on "effective ways" to make Member State healthcare systems economically sustainable.  The new advisory group will consist of 17 experts from several areas of health-related expertise, including pharmaceuticals and research and development.  Member States are reforming their health care systems to address the budgetary pressures stemming in p...
  • House PDUFA Draft: Make FDA's Review Process Take Into Account Job Creation

    Draft legislation to reauthorize a number of bills funding the US Food and Drug Administration (FDA) through user fees includes a provision to add economic considerations to the agency's mission, reports Med Page Today . The provision, put forth by Congressman Mike Rogers (R-MI), would mandate FDA take into account the promotion of economic growth and job creation in addition to its standing mandates to promote public health by ensuring medical products are safe and eff...