• ReconRecon

    Recon: Rigel wins first FDA approval; Abbott shares down as device sales grow

    • 18 April 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
  • Regulatory NewsRegulatory News

    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.
  • Regulatory NewsRegulatory News

    FDA Plans to Ramp Up Disease-Focused Guidance

    • 17 April 2018
    FDA Commissioner Scott Gottlieb on Tuesday told a House Appropriations subcommittee that the agency plans to “sharply increase” its release of disease-focused guidance documents to help drugmakers develop new treatments.
  • Regulatory NewsRegulatory News

    7 Questions for HHS and FDA: Grassley Targets Stem Cell Clinic

    • 17 April 2018
    Sen. Charles Grassley (R-IA) late last week sent a letter to HHS and FDA leadership, requesting more information about an unproven stem cell treatment that left several patients permanently blind.

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Most Viewed Articles

  • 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    A draft guidance the US Food and Drug Administration (FDA) revealed Wednesday sets the stage for how an existing 510(k) pathway will be expanded with the goal of providing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.
  • 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.
  • 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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