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  • End of the eCTD? FDA Pushes for New KASA System to Improve Assessments

    • 20 September 2018
    The US Food and Drug Administration’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee met Thursday to discuss the positive aspects of adopting a Knowledge-aided Assessment & Structured Application (KASA) platform.
  • Clinical Trials: FDA Releases Two Draft Guidances

    • 28 September 2018
    The US Food and Drug Administration (FDA) on Friday unveiled two draft guidances focused on adaptive clinical trial designs and master protocols for cancer treatment trials.
  • FDA Reveals Vision for the Transition to ISO 13485

    • 25 September 2018
    An apology was offered to device firms during a session at the MedTech Conference in Philadelphia on Tuesday by the US Food and Drug Administration (FDA) over its recently proposed overhaul of the quality system regulation.
  • Data Integrity a Top Concern for Manufacturers, FDA Says

    • 18 September 2018
    When a pharmaceutical or active pharmaceutical ingredient manufacturer has data integrity issues, that’s likely the tip of the iceberg, Sarah Barkow, of FDA’s Office of Manufacturing Quality, told attendees of the Pharma and Biopharma Outsourcing Association’s annual conference in Rockville, MD.
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