• Regulatory NewsRegulatory News

    EU Pharmacovigilance Fees Rise 1.7 Percent

    • 12 July 2018
    The European Commission on Wednesday raised the fees pharmaceutical companies pay related to pharmacovigilance activities in the EU by 1.7% to keep pace with inflation in 2017.
  • Regulatory NewsRegulatory News

    FDA to Form New Drug Shortages Task Force

    • 12 July 2018
    As the number of new drug shortages has steadily declined since 2011, the US Food and Drug Administration (FDA) on Thursday announced the creation of a new drug shortages task force, led by Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives, and including leaders from the Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs. 
     
  • Regulatory NewsRegulatory News

    Recon: Novartis joins exodus out of antibiotics

    • 12 July 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
     
  • Feature ArticlesFeature Articles

    Digesting FDA’s New Regulatory Definition of Dietary Fiber and its Impact on the US Food and Dietary Supplement Industry

    • 12 July 2018

    This article outlines the new regulatory definition of dietary fiber under the US Food and Drug Administration’s final rule for Nutrition and Supplement Facts labeling, including requirements for declaring ingredients as dietary fiber on the label outlined in the regulation.

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  • FDA Warns Chinese API Manufacturer for GMP Violations

    • 27 June 2018

    The US Food and Drug Administration (FDA) has warned Chinese active pharmaceutical ingredient (API) manufacturer Henan Lihua Pharmaceutical Co. Ltd. for good manufacturing practice (GMP) violations stemming from an inspection last December.

  • EU Recalls Some Valsartan Medicines Over Impurity

    • 06 July 2018
    EU authorities have initiated a recall of certain valsartan-containing medicines with active substance supplied by China-based Zhejiang Huahai Pharmaceuticals, pending a European Medicines Agency (EMA) review of an impurity detected.
     
  • FDA Unveils 6 New Draft Guidances on Gene Therapy

    • 11 July 2018
    As first announced in January, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Wednesday offered a swath of new draft guidance documents on human gene therapies – offering a look at what it expects from an industry that’s beginning to take off.
     
  • FDA to Release List of Surrogate Endpoints in Oncology

    • 25 June 2018
    Scott Gottlieb, FDA Commissioner, said Monday at the National Press Club in Washington, DC that his agency will release a list of surrogate endpoints used in cancer drug development soon.
     
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