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  • Regulatory NewsRegulatory News

    FDA Clears First Zika Diagnostic for Emergency Use

    The US Food and Drug Administration (FDA) on Friday approved the first diagnostic to detect the Zika virus under its emergency use authorization (EUA) pathway, which allows the agency to authorize unapproved products during a public health emergency. The authorization is significant as there are currently no other approved diagnostics available to detect Zika, a mosquito-borne virus that has rapidly spread across much of Latin America and the Caribbean and is thought to ...
  • Draft Guideline on Labeling Immunoglobulin Products Released by EMA

    The European Medicines Agency (EMA) has released a new draft guideline for sponsors of human normal immunoglobulin for subcutaneous and/or intramuscular administration pertaining to the summary of product characteristics (SmPC) required to be submitted to EMA and the European Commission. The guideline, released 31 July 2012 by EU regulators, notes sponsors of the products will be required to list different SmPCs on the product depending on whether it is intended for subc...