• Regulatory NewsRegulatory News

    FDA Warns of Increased Risk of Death With Gout Medicine Uloric

    • 22 February 2019
    The US Food and Drug Administration (FDA) on Thursday said it has concluded there is an increased risk of death with Takeda’s Uloric (febuxostat) when compared to another gout medicine, allopurinol, and the agency added a boxed warning to Uloric.
     
  • Regulatory NewsRegulatory News

    Catalyst Defends $375,000 Price Tag for Previously Free Drug

    • 21 February 2019
    In response to questions from Sen. Bernie Sanders (I-VT) on the price tag of a new orphan drug, Catalyst Pharmaceuticals on Thursday explained how much it had to invest in Firdapse (amifampridine) to bring it to market and how the previously experimental version of the drug should not be the standard of care.
     
  • Regulatory NewsRegulatory News

    Final FDA Rule to Require Foreign Device GCP Compliance Comes into Effect

    • 21 February 2019
    The US Food and Drug Administration (FDA) final rule that requires foreign clinical investigations for medical devices to comply with good clinical practice (GCP) requirements came into effect on Thursday.  
     
  • Regulatory NewsRegulatory News

    FDA Proposes New Rule for Sunscreen Products

    • 21 February 2019
    The US Food and Drug Administration (FDA) proposed a new rule on Thursday to update regulatory requirements for most sunscreen active ingredients currently on the US market.
     
  • Regulatory NewsRegulatory News

    EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials

    • 21 February 2019
    The European Medicines Agency (EMA) on Thursday opened for consultation a new guideline on the structure and data requirements for a clinical trial application for exploratory and confirmatory trials with advanced therapy investigational medicinal products (ATIMPs).
     
  • Regulatory NewsRegulatory News

    FDA Offers Guidance on Nicotine Replacement Therapies

    • 21 February 2019
    The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations to drugmakers looking to develop nicotine replacement therapy (NRT) products to help patients quit smoking.
  • Regulatory NewsRegulatory News

    Swissmedic Begins Working With EudraGMDP Database

    • 21 February 2019
    As part of the mutual recognition agreement between the EU and Switzerland, the Swiss Agency for Therapeutic Products (Swissmedic) has begun entering information on good manufacturing practice (GMP) compliance and manufacturing authorizations into the EU’s EudraGMDP database.
     

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