Federal Register notice: FDA issues an order permanently debarring Maytee Lledo from providing services in any capacity to a person that has an approv...
Federal Register notice: FDA classifies the general laparoscopic power morcellation containment system into Class 2 (special controls).
Sagent Pharmaceuticals recalls four lots of levetiracetam injection due to container closure integrity concerns.
The Sedgwick Recall Index for the third quarter shows that both medical device and drug recalls surged.
FDA extends for three months the PDUFA action date for Amryts NDA for Oleogel-S10 to treat cutaneous manifestations of junctional and dystrophic epide...
The Government Accountability Office reports that the FDA limited population pathway for antibacterial and antifungal drugs has gotten little use sinc...
CDER says its scientists are investigating how to improve pediatric dose selection by predicting drug clearance from renal function equations.
Two Hyman, Phelps medical device technical experts review provisions in a new FDA draft guidance on medical device software premarket submissions.