• Regulatory NewsRegulatory News

    EMA on Brexit: Risk for Drug Shortages Decreases

    • 22 March 2019
    As the UK and EU agreed to extend the Brexit deadline, the European Medicines Agency’s (EMA) Management Board said following its first meeting in Amsterdam that the prospect for centrally authorized products to be at risk of shortage “continues to decrease.”
     
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    Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

    • 21 March 2019
    Nonprofit advocacy group Public Citizen on Thursday filed a citizen petition calling for the US Food and Drug Administration (FDA) to impose a moratorium on approving new or reformulated opioids until the agency implements recommendations from a 2017 report by the National Academies of Science, Engineering and Medicine.
  • Regulatory NewsRegulatory News

    Reorganization of FDA’s Office of the Commissioner to Begin Soon

    • 21 March 2019
    Beginning 31 March, the US Food and Drug Administration’s (FDA) Office of the Commissioner will reorganize and make several changes to various offices within FDA, including the Office of New Drugs (OND).
     
  • Regulatory NewsRegulatory News

    UK Offers More No-Deal Brexit Guidance on Clinical Trials, PIPs

    • 20 March 2019
    With a glimmer of hope for a short extension to the Brexit deadline of 29 March, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is still releasing guidance in case Brexit occurs without a deal in place.
  • Regulatory NewsRegulatory News

    EMA Follows FDA Warning on Xeljanz Blood Clot Risks

    • 20 March 2019
    The European Medicines Agency (EMA) on Wednesday warned patients and healthcare professionals against exceeding the recommended dose of Pfizer’s rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) due to an increased risk of blood clots forming in the lungs.
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    Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies

    • 20 March 2019
    The US Food and Drug Administration (FDA) sent warning letters this week to two breast implant manufacturers over their failures to comply with FDA’s post-approval study (PAS) requirements.
     
  • Regulatory NewsRegulatory News

    OMB Reviews Proposal to Add Prices to Pharma TV Ads

    • 20 March 2019
    The Office of Management and Budget (OMB) this week began reviewing a proposed rule that would require drug companies to include list prices in direct-to-consumer television advertisements.
     

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