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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...
  • Regulatory NewsRegulatory News

    Health Canada Outlines 2016 Deficiencies at Actavis, Sanofi, Gilead and Other Manufacturing Facilities

    As part of Health Canada’s transparency push , the regulator is unleashing new information about its work, including an updated good manufacturing practice (GMP) inspection database that reveals new GMP deficiencies for Actavis, Sanofi-Aventis, Gilead, Baxter and other manufacturing facilities from inspections conducted in January 2016. Although none of the findings of the inspections have been listed on Health Canada’s inspection tracker , and specific details on the...
  • Facing Dire Shortage of IV Saline, FDA Again Turns to Enforcement Discretion Approach

    In the face of mounting concerns about a shortage of intravenous saline solutions, the US Food and Drug Administration (FDA) announced it is once again utilizing an uncommon regulatory mechanism to ease the shortage-a mechanism no longer on the strongest of legal footings. Background Drug shortages have been an ongoing problem in the US since at least 2011, and have been blamed on a number of causes, including quality problems at manufacturing facilities, overly aggr...
  • GMP Deficiencies in Spotlight in Warning Letters to Amgen, Baxter

    Life science manufacturing giants Baxter Healthcare and Amgen were each sent Warning Letters by the US Food and Drug Administration (FDA) in January 2014 chiding them for medical device manufacturing problems at their respective facilities. Amgen Letter The Amgen letter refers to a June 2013 inspection of the company's Thousand Oaks, CA facility where it makes three products: Prolia with prefilled syringe and manual needle guard Enbrel lyophilized vial and diluent ...