RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • 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...
  • 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...