• RAPS' LatestRAPS' Latest

    Focus on: Daniela Drago

    • 17 May 2018
    A conversation with Daniela Drago, head of the regulatory affairs program at The George Washington University and chair of the RAPS DC/Baltimore Chapter, as part of our new Regulatory Focus interview series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers from a variety of backgrounds.
  • Regulatory NewsRegulatory News

    US WorldMeds Wins FDA Nod for First Non-Opioid to Treat Opioid Withdrawal Symptoms

    • 16 May 2018
    Specialty drug company US WorldMeds’ Lucemyra (lofexidine hydrochloride) became the first non-opioid treatment for the management of opioid withdrawal symptoms among adults to receive US Food and Drug Administration (FDA) approval on Wednesday, according to an agency announcement.
     
  • Regulatory NewsRegulatory News

    FDA Hones In On Critical Issues With Recruitment, Inclusion of Women in Clinical Trials

    • 16 May 2018
    The US Food and Drug Administration (FDA) is looking to break down barriers hindering the availability of clinical trial data on women by focusing on two critical issues--enrollment and new products designed for treating conditions that are gender-unique.
     
  • Regulatory NewsRegulatory News

    FDA Faster Than Global Peers at Approving New Drugs

    • 16 May 2018
    A report from the Centre for Innovation in Regulatory Science (CIRS) released this month finds that the US Food and Drug Administration (FDA) has reclaimed its position as the fastest major regulator for approving new drugs and biologics.

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Most Viewed Articles

  • FDA Goes All Out With Digital Health Regulatory Paradigm Shift

    • 26 April 2018
    From the launch of a premarket digital safety program, to the release of new policies for multi-function device products, FDA Commissioner Scott Gottlieb made a plethora of announcements at the Health Datapalooza conference Thursday.
  • FDA Withdraws Final Rule to Cut Biologics Inspections

    • 04 May 2018
    The US Food and Drug Administration (FDA) on Friday withdrew a direct final rule that would have amended the general biologics regulations on inspection time requirements and would have removed inspector requirements.
  • MHRA Reveals 5-Year Plan, Seeks Clarity Post-Brexit

    • 24 April 2018
    A new five-year corporate plan the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) revealed Tuesday highlights how the agency intends to “become a real world regulator” and to “ensure a smooth EU exit under any scenario.”
  • Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    • 30 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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