• Regulatory NewsRegulatory News

    African Union, WHO Team Up to Launch African CDC

    Officials at the African Union Commission (AUC) and the World Health Organization Regional Office for Africa (WHO/AFRO) are looking to address the shortcomings of the international response to the Ebola crisis by launching a new disease monitoring agency, the Centres for Disease Control and Prevention in Africa (African CDC). Background Africa has the world's highest burden of disease , with far higher mortality rates for infectious diseases than any other region. Many...
  • Regulatory NewsRegulatory News

    FDA, CDC Preparing Updated Form to Record Vaccination Problems

    The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form. Background In a notice published in the Federal Register on 24 November 2014, CDC said it's accepting public input on its proposed Vaccine Adverse Event Reporting System (VAERS) 2.0 form. VAERS is used by FDA and CDC, which co-administer th...
  • Regulatory NewsRegulatory News

    FDA Review Finds Storage Problems at Food, Supplement Regulator CFSAN

    The US Food and Drug Administration (FDA) has announced that it has found still more vials of improperly stored hazardous substances in one of its labs, just weeks after the agency announced that it had found dozens of other vials of hazardous substances, including the smallpox virus. Background In July 2014, FDA and the National Institutes of Health (NIH) announced they had discovered previously unknown vials containing variola—the virus which causes smallpox—as well...
  • FDA Again Leverages Emergency Use Authority, Seeking to Stay Ahead of Deadly Mystery Virus

    For the second time in as many months, US regulators have leveraged new authority granted to them under recently-passed anti-bioterrorism legislation that allows them to approve products based on an understanding that an emerging virus could become a threat to public health. This time, however, the emerging virus is far different than the typical strains of influenza public health officials usually grapple with. Background In March 2013, the US Food and Drug Administrat...
  • FDA, Others Plan Meeting to Address Antimicrobial Resistance

    Three US healthcare agencies, including the US Food and Drug Administration (FDA), are planning to hold a meeting in November on the topic of antimicrobial resistance, and in particular the progress made to combat resistance and further steps to be taken. The meeting, announced in a Federal Register posting on 19 September , will also involve the Centers for Disease Control and Prevention (CDC) and the National Institutes of health (NIH), all of which are located wi...
  • Bill Proposes National Tracking System for Drug Overdoses

    • 21 August 2012
    The Centers for Disease Control and Prevention (CDC) would be tasked with compiling, analyzing and publishing data on drug overdoses if a new piece of proposed legislation is signed into law. The bill, the Stop Overdose Stat Act (S.O.S. Act) , is more broadly intended to reduce the number of drug overdoses occurring in the US. The bill notes more than 36,000 Americans died from drug overdoses in 2008, with approximately three-in-four of these deaths resulting from a...
  • After Flu Concerns, Regulators Look to Issue Guidelines on 'Dual Use' Preclinical Studies

    International healthcare bodies are looking to issue guidelines on 'dual use' research on potentially hazardous materials and diseases after a researcher sent shockwaves through the medical community in 2012 for his re-engineering research on a potentially deadly strain of bird flu, reports The Financial Times. "Washington has just issued new guidelines; the Royal Society, the British scientific organization, rushed to convene a high-level session last week on the topi...
  • FDA Gets New COO

    Biocentury reports US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has tapped Walter Harris, currently at the Centers for Disease Control and Prevention (CDC), to be FDA's new Chief Operating Officer (COO). At CDC, Harris served as both the Chief Human Capital and Resources Officer and the Deputy Director of the Office of Surveillance, Epidemiology and Laboratory Services (OSELS). Before arriving at CDC, Harris served as Acting Chief Information Off...