FDA didn't properly inform plaintiffs about requirements for a successful application. Read More
Tags :Triton Distribution
The case will now be decided by a panel of all active Fifth Circuit judges.Read More
The Fifth Circuit denied the companies' requests Monday for review of the agency’s orders.Read More
Judges say the FDA pulled a “surprise switcheroo” in changing its PMTA guidance.Read More
The company claims the FDA retroactively changed the requirements for applications. Read More