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More than two years after receiving an FDA rejection, Mesoblast has resubmitted its biologics license application (BLA) for remestemcel-L, a treatment for children afflicted with steroid-refractory acute graft vs. host disease (SR-aGVHD). Read More
The FDA has warned consumers not to use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination that has caused permanent vision loss from eye infections and one death. Read More
As the Biden administration prepares to end the COVID-19 public health emergency on May 11, the FDA must decide what to do with dozens of temporary guidances issued during the public health emergency. Read More
In this special report, Drug Industry Daily examines how the drug supply chain has evolved during the pandemic. Part 2 focuses on efforts to shore up the supply chain, including the promotion of domestic manufacturing.Read More
Becoming — and remaining — in compliance with FDA regulations is often a result of creating and maintaining a quality culture but measuring the maturity of that culture takes more than just looking at metrics, according to several experts speaking at a recent FDAnews webinar. Read More