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Two Hyman, Phelps medical device technical experts review provisions in a new FDA draft guidance on medical device software premarket submissions.
The House Select Committee on Covid-19 asks former FDA commissioner Stephen Hahn for documents and an interview on Trump administration efforts to inj...
FDA grants Isofol Medical a fast track designation for arfolitixorin, a stabilized and biologically active pure form of folate ([6R]-MTHF) for treatin...
New financial disclosure documents show Robert Califf earned millions of dollars last year from industry, which could disrupt the confirmation process...