• Regulatory NewsRegulatory News

    Interview With Gottlieb: A Discussion on Biosimilars, Opioids and Transparency

    • 20 April 2018
    FDA Commissioner Scott Gottlieb spoke with Focus on Friday in a phone interview on the uptake of biosimilars in the US, generic drug labeling, the opioid crisis and FDA transparency. The interview was lightly edited for clarity.
  • Regulatory NewsRegulatory News

    Australia Proposes Changes to Biologics Regulations

    • 20 April 2018
    Australia’s Therapeutic Goods Administration (TGA) on Friday released proposed changes to its biologics regulatory framework, to take effect on 1 July 2018, that would regulate certain treatments that were previously excluded from the regulations.
     
  • ReconRecon

    Recon: Biogen Strikes $1B Deal With Ionis for Neurology Drug Development

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

    Expanded Access Programs: Making Compassion Work

    • 20 April 2018

    This article discusses issues and efforts related to expanded access programs aimed at providing patients with quicker access to new and experimental drugs, many of which are potentially lifesaving. The perspectives of health authorities, industry and patients are explored as well as the historical legal and ethical issues involved in ensuring expanded access drugs are safe and efficacious.

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  • FDA Director Moves to AstraZeneca

    • 18 April 2018
    Twenty-year FDA veteran Badrul Chowdhury, most recently director of the Center for Drug Evaluation and Research’s (CDER) Division of Pulmonary, Allergy and Rheumatology Products, has taken a job this month as senior vice president at AstraZeneca.
  • FDA Proposes New Option for Device Companies to Apply for 510(k) Clearance

    • 11 April 2018
    A draft guidance the US Food and Drug Administration (FDA) revealed Wednesday sets the stage for how an existing 510(k) pathway will be expanded with the goal of providing firms greater flexibility.
  • Amgen Seeks Clarity on Whether Biologics' Suffixes Could Cause Misbranding or Adulteration Issues

    • 27 March 2018
    Amgen is raising questions about whether the addition of suffixes to nonproprietary names of biologics and biosimilars could cause the products to be deemed by the US Food and Drug Administration (FDA) to be misbranded or adulterated because they do not adhere to the appropriate USP monographs.
     
  • Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    • 17 April 2018
    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.
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