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The news that the Biden Administration is considering asking Robert Califf to return as Commissioner of the US FDA is the latest twist in a most unusual transition process at the agency. But one message seems abundantly clear: the White House is perfectly happy with FDA as it is.
Agency’s apparent ‘intellectual exercise’ in treating pre-Hatch-Waxman ANDAs as NDAs could expose biosimilars to liability, Teva deputy general counsel notes at FDLI conference.
A new study highlights a subset of high-cost drugs in Medicaid for which legal and policy tools may be available to manage spending growth.