• Regulatory NewsRegulatory News

    SCOTUS Says Judge, Not Jury, Should Decide Merck Drug Labeling Case

    • 20 May 2019
    In cases where state failure-to-warn claims should be dismissed as pre-empted by federal law, the Supreme Court on Monday unanimously ruled that judges, rather than juries, are better equipped to evaluate the nature and scope of an agency’s, such as the US Food and Drug Administration (FDA), determination.
  • Regulatory NewsRegulatory News

    FDA Officials Explain When Litigation Can Impact Drug Safety Signals

    • 20 May 2019
    The submission of litigation-associated adverse event reports (LARs) to the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) can have an impact on detecting safety signals, Monica Muñoz and Gerald del Pan of FDA’s Office of Surveillance and Epidemiology wrote recently in a research letter to the journal Drug Safety.
     
  • Regulatory NewsRegulatory News

    UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

    • 20 May 2019
    In preparation for the future of clinical trials under EU Clinical Trial Regulation 536/2014, the UK has been running a pilot program for a little more than a year to streamline the submission and review process for applications to run Clinical Trials of Investigational Medicinal Products (CTIMPs).
     
  • Regulatory NewsRegulatory News

    Groups Seek More FDA Flexibility in Early Cell Therapy Development

    • 20 May 2019
    A new white paper from the Friends of Cancer Research (FOCR) and the Parker Institute for Cancer Immunotherapy calls on the US Food and Drug Administration (FDA) to ease clinical and manufacturing requirements to speed early development of anti-cancer cell therapies.

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  • Almost Half of All New Drug Approvals in 2018 Relied on One Clinical Trial

    • 14 May 2019
    Back in the 1970s and 1980s, the US Food and Drug Administration (FDA) made clear that at least two adequate and well-controlled studies were necessary to establish a new drug’s effectiveness, except in only the rarest of circumstances.
     
  • ICH Updates: What’s Coming in 2019 and Beyond

    • 29 April 2019
    US Food and Drug Administration (FDA) officials on Monday morning held a meeting to offer a rundown of what needs to be done and what to expect from more than a dozen different International Council for Harmonisation (ICH) guidelines.
     
  • FDA Raises Concerns With Novartis in Clinical Inspection

    • 06 May 2019
    As part of Novartis’ new drug application for its recently approved multiple sclerosis drug Mayzent (siponimod), the US Food and Drug Administration (FDA) questioned the drugmaker’s data practices during a clinical inspection.
  • Woodcock Details Upcoming Changes to NDA and BLA Review Process

    • 02 May 2019
    A modernization of the way the US Food and Drug Administration (FDA) reviews new drug applications (NDAs) and biologic license applications (BLAs) will be instituted over the next two years, Center for Drug Evaluation and Research (CDER) Director Janet Woodcock told attendees of the Food and Drug Law Institute’s annual conference on Thursday.
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