• Regulatory NewsRegulatory News

    FDA Approves More Drugs First Than EMA and Swissmedic, Comparison Finds

    • 23 February 2018
    From 2007 to 2016, the US Food and Drug Administration (FDA) approved more new drugs and biologics first than its European and Swiss regulatory counterparts, according to a comparison published in the European Journal of Clinical Pharmacology.
     
  • Regulatory NewsRegulatory News

    FDA and Health Canada to Jointly Discuss ICH Topics

    • 22 February 2018
    Ahead of the International Council of Harmonisation’s (ICH) June meeting in Kobe, Japan, the Canada-US Regulatory Cooperation Council (RCC) will meet to discuss areas where harmonized ICH guidelines could be beneficial.
  • Regulatory NewsRegulatory News

    CBER Director Discusses Regulation of Human Genome Editing

    • 22 February 2018
    With more than a dozen companies developing gene editing medicines, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Director Peter Marks discussed the risk-based approach his center is taking
  • Regulatory NewsRegulatory News

    NPPA Reverses Course, Allows Stent Manufacturers to Cease Sales in India

    • 22 February 2018
    Following a decision to extend imposed price controls on coronary stents through 2019, India’s National Pharmaceutical Pricing Authority (NPPA) has revised its policies to allow manufacturers to discontinue sales.
     
  • Regulatory NewsRegulatory News

    'Anti-Aging' Company Settles With FTC Over False Claims

    • 21 February 2018
    New York-based Telomerase Activation Sciences on Wednesday agreed to stop making false and unsubstantiated claims about two “anti-aging” products under a Federal Trade Commission (FTC) settlement order.
     
  • Regulatory NewsRegulatory News

    FDA's OPDP Sends First Untitled Letter of 2018

    • 21 February 2018
    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) earlier this month sent its first untitled letter of 2018 to Canton, MA-based drugmaker Collegium Pharmaceutical over an exhibit promoting the company's opioid drug Xtampza ER (oxycodone).
  • Regulatory NewsRegulatory News

    DC District Court Rules in Favor of FDA in Amgen Pediatric Exclusivity Case

    • 21 February 2018
    For the second time in the last month, the District of Columbia's District Court took the US Food and Drug Administration's (FDA) side in the agency's decision to deny a six-month extension of market exclusivity for Amgen's blockbuster Sensipar (cinacalcet).
  • Regulatory NewsRegulatory News

    India’s Drug Regulator Sees Top-Level Shakeup

    • 21 February 2018
    GN Singh, the Drug Controller General of India (DCGI) since 2012, has been relieved of his post, according to a circular distributed by India’s Ministry of Health and Family Welfare.

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