• Regulatory NewsRegulatory News

    EMA to Continue to Allow Patient Involvement in CHMP Meetings

    The European Medicines Agency (EMA) said Monday that it will continue to allow patients to offer viewpoints during the assessments of the benefits and risks of medicines before its Committee for Medicinal Products for Human Use (CHMP). In addition to continuing to invite patients to oral explanations on a case-by-case basis, EMA will also look to use additional methods and consult patients on a more regular basis. "This could include participating in CHMP discuss...
  • RAPS' LatestRAPS' Latest

    Knowledge Center Provides RAPS Members With Free Content

    • 13 June 2016
    RAPS members now have a new and powerful tool to help them stay informed. The Member Knowledge Center , a new members-only content portal, provides a catalog of carefully curated free RAPS resources in one convenient place. The Knowledge Center gives members exclusive access to RAPS’ educational resources. “We wanted to find a way to help our members engage with RAPS’ high-quality products,” said Lindsay Currie, RAPS’ director of stakeholder engagement. “We plan to regu...
  • FDA in Sustained Push to Show Public Benefits of Regulatory Science

    Can regulatory science -that is, the use of various scientific disciplines to make informed decisions about the safety, efficacy or quality of a particular product-ever be exciting to the average citizen? Regulators with the US Food and Drug Administration (FDA) hope so, and are in the midst of a sustained public relations push to give the burgeoning field a bit more exposure and appreciation. In a posting on 6 November, FDA's Susan Kelly, managing editor of consume...
  • Complicated Math Decides UK Patient Access to New Drugs

    The Citizens Council of the UK's National Institute for Health and Clinical Excellence (NICE), which provides public input into the Institute's work, has published its final report on a November 2011 meeting on the issue of how NICE should assess future costs and health benefits. The Council members' views on the issue of discounting -the way in which health benefits are valued and calculated over a very long period of time-will be used to guide the methods used by NI...