FDA issues an internationally harmonized guidance on the nature and types of data that can be useful in determining a toxicological acute reference do...
FDA clears a RevMedx 510(k) for the XSTAT 12 and XSTAT 30 hemostatic devices for controlling severe, life-threatening bleeding from narrow entrance ex...
Eli Lilly CEO David Ricks says he expects an executive order on lowering drug prices by years end.
CDRH releases an online information sheet on its Early Feasibility Study program.
Centurion Labs recalls one lot of Ninjacof and one lot of Ninjacof A manufactured by Vilvet and distributed by Centurion Labs to the retail level due ...
FDA Deputy Commissioner and Office of Medical Products and Tobacco director Rachel Sherman accepts the position principal deputy commissioner.
Ultragenyx says it will terminate development of aceneuramic acid extended release after it failed to meet key primary and secondary endpoints in a Ph...
ChromaDex asks FDA to declare Elysium Healths Basis supplement product to be adulterated because it uses an ingredient that is not generally recognize...