Radiopharmaceutical drug manufacturers say they need more consistency from FDA in inspections and regulatory operations.
The U.S. Supreme Court hands a victory to Hikma Pharmaceuticals in a closely watched case testing the patent risks of FDA-approved "skinny label" generics, rejecting Amarin Pharma's infringement claims involving the cardiovascular drug Vascepa
Radiopharmaceutical drug manufacturers say they need more consistency from FDA in inspections and regulatory operations.
The U.S. Supreme Court hands a victory to Hikma Pharmaceuticals in a closely watched case testing the patent risks of FDA-approved "skinny label" generics, rejecting Amarin Pharma's infringement claims involving the cardiovascular drug Vascepa
FDA posts a guidance outlining its intent to exempt several low-risk, unclassified medical devices from premarket notification requirements.
A Friends of Cancer Research white paper recommends three ways the FDA Biomarker Qualification Program could be improved.
