Patricia Van Arnum

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.

The company expands to add process-development and clinical-manufacturing capabilities at its large-scale bulk biologics facility.

Company is notified of GMP violations at facility in Catania, Italy.

Maryland is the latest state to consider whether to include additional requirements for substitution of biological products.

Company considers investment in insulin cartridge-filling and insulin API manufacturing capacity in the US.

Company issues voluntary recall after learning of complaints of an uncharacteristic odor coming from Levoxyl bottles.

Novartis loses an appeal in seeking patent protection in India for its anticancer drug.

CROs are keeping pace with the increased globalization of the biopharmaceutical/pharmaceutical industry.