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  • Regulatory NewsRegulatory News

    More Than 100 Days After Hurricane Maria, Drug Shortages Situation Expected to Improve

    The US Food and Drug Administration (FDA) on Thursday announced that shortages of IV saline are expected to improve early this year as Baxter – a leading producer of IV saline fluids – has said all its facilities on Puerto Rico have now returned to the commercial power grid. The good news on Baxter comes as the agency said all other companies that were on an initial list of drugs considered at risk of potential shortages – because the drugs were largely or entirely...
  • Regulatory NewsRegulatory News

    FDA Allows Temporary Saline Imports to Deal With Shortages Caused by Hurricane Maria

    Baxter Healthcare said in letters to health care professionals dated Monday that it is working with the US Food and Drug Administration (FDA) to import sodium chloride and glucose intravenous infusion products from Ireland and Australia to address shortages because of Hurricane Maria. The temporary imports are manufactured at Baxter facilities in Ireland and Australia and the company notes that at this time, "No other entity except Baxter is authorized by the FDA t...
  • FDA Says Hurricane Sandy Will Affect Review Target Dates, Regulated Industry

    Hurricane Sandy left much of the US' eastern seaboard battered and flooded after coming ashore in late October, and the damage and delays it caused are having regulatory implications, the US Food and Drug Administration (FDA) said in an announcement. In a 1 November 2012 statement , FDA Commissioner Margaret Hamburg said her agency was heavily focused on the storm and its potential to affect regulated industry. "We often think of major storms like Sandy in terms of th...