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  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance aimed at increasing diversity in clinical trial populations as part of its efforts to encourage drugmakers to enroll populations that more closely reflect the populations that will take the drugs in the real world.   “This guidance recommends approaches that sponsors of clinical trials to support a new drug application [NDA] or a biologics license application [BLA] can take to broaden eligibi...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Targeted Therapies in Rare Genetic Subsets

    The US Food and Drug Administration (FDA) on Monday finalized guidance on developing targeted therapies in rare molecular subsets of diseases.   The 9-page guidance finalizes a draft version released in December 2017 and has been updated to incorporate comments submitted to the public docket and includes minor edits to improve clarity.   “By providing clarity on the regulatory and scientific frameworks for product developers, safe and effective targeted treatment...
  • Regulatory NewsRegulatory News

    Antimicrobial Susceptibility: FDA Launches Test Website, Issues Guidance

    The US Food and Drug Administration (FDA) on Wednesday launched a new website aimed at improving access to information that can help healthcare professionals determine which drugs are most likely to work to treat bacterial or fungal infections. The website is part of an effort mandated by the 21st Century Cures Act to combat rising antimicrobial resistance by providing a central, easily accessible and up-to-date repository for antimicrobial susceptibility interpretive ...
  • Regulatory NewsRegulatory News

    FDA, NIH Unveil Initial Framework for Biomarker Qualification

    Officials from the US Food and Drug Administration (FDA), the Foundation for the National Institutes of Health (NIH) and other stakeholders, including experts from Genentech, Merck, Pfizer and Takeda, have released a framework for proposed evidentiary criteria to support the regulatory acceptance of biomarker use in drug development programs. The framework, released 6 December, is expected to help support FDA in the development of relevant guidance(s) for evidentiary cr...