Public Citizen says that only four of 29 drug companies surveyed would agree to limit price increases to single digits for more than one year.
FDA clears a Becton Dickinson 510(k) for a flow cytometer system with a leucocount reagent assay used in residual white blood cell enumeration.
Attorney David Fox says that the biosimilar industry and FDA are where they need to be in the process at this time.
FDA issues Nanobiosym Diagnostics an emergency use authorization for the Gene-RADAR Zika Virus Test.
Bipartisan legislation is introduced to ensure that generic drug developers have access to needed reference-listed product samples.
FDA warns Mylan about CGMP and data integrity violations at its finished pharmaceuticals plant in Maharashtra, India.
A Morning Consult op-ed by ex-FDAers urges President Trump to back four steps on promoting generic drugs, improving drug quality, easing regulatory bu...
Medtronic recalls all unused units of the StrataMR adjustable valves and shunts due to an increase in product complaints, a rate estimated at 2.75% pe...