• Regulatory NewsRegulatory News

    New MAPP details when FDA notifies drugmakers about ARIA studies

    In a new manual of policies and procedures (MAPP) released on Monday, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) explains how and when it will notify applicants when the agency plans to study a product using its Sentinel active risk identification and analysis (ARIA) system.   Before FDA can require a postmarketing study or clinical trial for a drug, it must determine whether its ARIA system or adverse event reporting sys...
  • Regulatory NewsRegulatory News

    Woodcock: Drug Safety Surveillance System Ready for Full Operation

    The US Food and Drug Administration's (FDA) Sentinel database tracking medical product safety events is now an "integral part of routine safety surveillance," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA said at the 8 th Annual Sentinel Initiative Public Workshop in Washington, DC, Wednesday. "We can, as of today, officially drop 'Mini' from the Sentinel title," she said, noting the progress made since the agency began transition...