• Regulatory NewsRegulatory News

    The Essential List of Regulatory Authorities in Asia

    To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.   For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unc...
  • Regulatory NewsRegulatory News

    FDA Approving Most New Drugs and Biologics During Their First Review, Report Finds

    The US Food and Drug Administration's (FDA) is now approving more new drugs and biologics during their first review cycles than at any time since at least 2008, a new FDA-commissioned report shows. Background The report , conducted by the Eastern Research Group (ERG) on behalf of FDA, is focused on the fifth iteration of the Prescription Drug User Fee Act (PDUFA) , which was passed in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) . P...