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    FDA Recommends Against Use of Painkillers for Teething Pain

    US Food and Drug Administration (FDA) regulators are warning that young children who are teething and experiencing pain should not be given lidocaine, a topical painkiller, due to the serious and even fatal risks associated with the drug. In a 26 June announcement , FDA said that the application of oral viscous lidocaine 2% solution had been associated with at least 22 reports of serious adverse reactions, "including deaths," in young children and infants. At leas...
  • CBER Wants Better Vaccine Safety, Identify Adverse Events

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is announcing its intent to launch a program to ensure the safety of vaccine products manufactured around the globe by enhancing the regulatory capacity of emerging nations. CBER's initiative, dubbed the "Global Regulatory Utilization of Vaccine Safety and Surveillance (GRUVSS) initiative," is in response to what FDA described as a "dramatic increase in the global use of vacci...