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

 
  • Regulatory NewsRegulatory News

    FDA Warns Fresenius Kabi Subsidiary Over Promotional Materials

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has warned Fenwal, a Fresenius Kabi subsidiary, for the second time due to promotional materials for the company's platelet additive solution. FDA first approved Fenwal's new drug application (NDA) for InterSol (500mL platelet additive solution 3) in 2009 as a storage solution to replace a portion of the plasma in platelets collected via the company's Amicus apheresis devi...
  • Court: 'Pay-for-Delay' Practice Anticompetitive, Illegal

    In a potentially precedent-setting decision, a federal court has declared that payments made by companies to delay generic competition-also known as pay-for-delay settlements-are anti-competitive and illegal. The lawsuit, filed in the Third Circuit Court of Appeals in California, involved some of the pharmacy and pharmaceutical industry's largest companies, including CVS Pharmacy, Rite Aid, Walgreen, and Merck. The case was also supported by the Federal Trade Commissio...
  • Obama Administration, Plaintiffs File PPACA Briefs

    The US Department of Justice (DOJ) and a group of 26 states ("state petitioners") both filed briefs with the Supreme Court of the United States (SCOTUS) on Friday, 6 January outlining their respective arguments regarding the Patient Protection and Affordable Care Act's (PPACA) constitutionality and the severability of certain components of the law. The DOJ brief focuses on the question of whether or not "the minimum coverage provision is a valid exercise of Congress...