• New ISO/IEC Guide Addresses Medical Device Safety Regulations

    A new guide put forth by the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) aims to address medical device safety by guiding the development of new safety standards. ISO/IEC Guide 63:2012,  Guide to the development and inclusion of safety aspects in international standards for medical devices , seeks to improve upon earlier ISO guides by promoting the "optimal use of resources" through limiting the development of...
  • CDER Launches New Training Tool For International Regulatory Bodies

    The US Food and Drug Administration (FDA) released a new training tool to the public on 24 February for  international regulators to "learn first-hand how [the Center for Drug Evaluation and Research (CDER)] organizes the drug review process and carries out its mission of ensuring the safety and efficacy of human drug products in the US." The tool, CDER World , acts as an Internet-based "compendium of information" about how CDER operates as an agency, adapts to t...
  • FDA Sends Warning Letter For Lack of Quality Agreement

    • 23 February 2012
    The US Food and Drug Administration (FDA) sent a warning letter to FSC Laboratories for failure to establish a quality agreement with the manufacturer of its drug delivery device, according to a report by Outsourcing Pharma . The letter, written in June, but published this week, found FSC's overall quality plan "adequate," but FDA raised several points for the company to examine. Outsourcing Pharma reported quality agreements are important to FDA. Acting associa...