RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • EMA Launches EU-Wide Investigation into Roche for Alleged Pharmacovigilance Deficiencies

    The European Medicines Agency (EMA) has announced the start of an investigation into Roche Registration-the EU subsidiary of Roche-after UK regulators conducting an inspection found, "Serious shortcomings" in the company's pharmacovigilance processes. The investigation could be the first major test of the EU's recently passed pharmacovigilance legislation. EMA has previously blasted the company in a June 2012 statement regarding the same incident, saying the company ...
  • EMA Slams Roche Over Extensive Safety Reporting 'Deficiencies'

    The European Medicines Agency (EMA) released a statement on 21 June slamming Roche for alleged deficiencies in the company's medicines safety reporting, saying it had been made aware a cache of 80,000 potential adverse event reports that the company had failed to evaluate and submit to EU regulators. The allegations stem from a May 2012 report by the UK Medicines and Healthcare products Regulatory Agency (MHRA), which had inspected the company under a routine inspection ...
  • FDA Releases Strategic Plan for Veterinary Medicine Program

    The US Food and Drug Administration (FDA) has released a new strategic plan for its veterinary medicine program for the 2012-2016 period, outlining the regulatory goals for FDA's Center for Veterinary Medicine. The plan, intertwined with FDA's plan for the Center for Food Safety and Applied Nutrition (CFSAN), provides seven "strategic program goals" and dozens of specific initiatives meant to carry out those strategic program goals. FDA's Foods and Veterinary Medicine...
  • Senators Call for Task Force on Adverse Drug Reactions

    • 03 January 2012
    A study in the New England Journal of Medicine (NEJM) has prompted two Senators to call for a joint task force to be created. Sens. Olympia Snowe (R-ME) and Michael Bennet (D-CO) have requested that the US Department of Health and Human Services Convene a multi-agency task force to, according to The Hill journalist Julian Pacquet, "help identify patients at risk for adverse drug reactions." The request was inspired by a NEJM article that found that four types of m...