A rare disease coalition calls on the Trump administration to appoint a new CBER director who understands rare disease drug development and values the views of patients and doctors.
An FDA untitled letter cautions the Fort Myers, FL-based LeeSar drug outsourcing facility about CGMP and other violations in its production of compounded drugs.
A rare disease coalition calls on the Trump administration to appoint a new CBER director who understands rare disease drug development and values the views of patients and doctors.
An FDA untitled letter cautions the Fort Myers, FL-based LeeSar drug outsourcing facility about CGMP and other violations in its production of compounded drugs.
FDA warns Clifton, NJ-based Physitemp Instruments about Quality System, Medical Device Reporting, Unapproved Device, and Unique Device Identifier violations in its production of electronic thermometers and needle probes.
A Courthouse New Service report outlines the competing arguments made before a three-judge appeals court panel in a case involving FDA’s decision to remove Zepbound, Ozempic, and Wegovy from its shortage list, effectively banning compounded versions of the weight-loss drugs.
