• Regulatory NewsRegulatory News

    FDA, CDC Put $18M Behind Adverse Event System for Vaccines

    The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have awarded a new, $18 million contract meant to support its existing Vaccine Adverse Event Reporting System (VAERS) over the next five years. The award will go to Virginia-based SRA International, the company announced in a 17 November 2014 press release . SRA has supported FDA's VAERS program since 1999, it said. VAERS is used by FDA to collect and analyze reports of vacci...
  • Regulatory NewsRegulatory News

    Public Comment Period Opens on ISO 9001, Major Device Quality Standard

    The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation. Background The standard, which covers Quality Management Systems (QMS), undergoes  a revision process once every five years, and was last updated in 2008 (ISO 9001:2008). The ISO 9001 standard is used extensively throughout the medical...
  • CDSCO Clarifies the Role of its International Unit

    India's Central Drugs Standard Control Organization (CDSCO) has posted the organizational structure and functions of its recently-formed International Cell , which interfaces with foreign governments and regulatory agencies and investigates reports of quality concerns with India drug exports.  Among its other functions, the Cell focuses on bilateral Memoranda of Understanding (MOUs), grants written confirmations for active pharmaceutical ingredient (API) exports f...
  • The Top 10 Regulatory Stories of 2012 (International Edition)

    • 14 January 2013
    2012 was a momentous year for both the regulatory profession and  Regulatory Focus . In our first year as an online-only publication, we covered a quickly changing landscape, dealing with topics that ranged through the quality of pharmaceutical products, the passage of new legislation, the safety of medical devices and the legal issues surrounding product regulation and marketing. So what happened this year in global regulatory? We're glad you asked. The editors and...
  • New ISO Standard Released for Characterizing Nanoparticles

    The International Standards Organization (ISO), an international body whose standards are often used by regulatory authorities, has unveiled new guidance on conducting toxicology tests on nanomaterials. ISO's 3 July 2012 technical report, "Nanotechnologies - Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment" (ISO/TR 13014:2012) is intended to be used to help researchers understand a nanomaterial's physicochemical ...
  • World: Regulatory Agencies Attend WHO Seminar

    Numerous regulatory agencies met on 18 May in Geneva, Switzerland to discuss whether it is possible to find new ways to allow their drug regulatory bodies to cooperate. The meeting, an international seminar hosted by the World Health Organization (WHO), included representatives from Australia, Argentina, Brazil, France, India, Portugal, South Africa, the United States and the UK. A total of 30 regulatory agencies attended the meeting. The meeting coincided with the WHO'...
  • 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...