Attorney Anne Walsh questions the creative Justice Department enforcement action against Baxter using a False Claims Act settlement to resolve cGMP is...
FDA clears an Alere 510(k) for the Alere Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings.
FDA and Emulate enter into a Cooperative Research and Development Agreement to evaluate and qualify the use of Emulates Organs-on-Chips technology as ...
FDA releases its latest batch of Warning Letters that cite Indoco Remedies and Mylan Pharmaceuticals.
McCullough Robertson attorneys examine the default provisions in the BPCIA patent dance and how they can be negotiated to set prosecution and regulato...
FDA warns Indias Indoco Remedies about repeat CGMP violations in the production of finished pharmaceuticals.
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.