• FDA Announces New Meetings, Workshops

    The US Food and Drug Administration (FDA) announced three new advisory committee meetings and a new workshop in the Federal Register  on 23 May 2012. Regulatory Focus is pleased to present you with a brief summary of their respective topics. Meeting: Oncologic Drugs Advisory Committee The committee will discuss and provide general advice on the extent to which, if any, the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test ...
  • IOM Releases Report on Biomarkers and Surrogate Endpoints

    The Institute of Medicine (IOM) released a workshop summary on 14 February that explores the evaluation process for biomarkers used to detect surrogate endpoints in chronic diseases. An initial report, Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease , was requested by the US Food and Drug Administration (FDA), and released by IOM in May 2010. Biomarkers are "indicators of normal biological processes, pathogenic processes or pharmacologic response...