• 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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