Bextra "Likely" To Add Black Box Warning, Pfizer Says
Pfizer expects that resolution of labeling discussions with FDA will include boxed warning about skin reactions. FDA will have to consider whether to handle issue in context of broader COX-2 class safety review.
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Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.
China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.