Members of FDA Risk Communications Advisory Committee. Wyeth R&D senior execs meet with FDA drug review managers in September 2007. Oncologists, an ex-Congresswoman, and a former Bush Administration health policy advisor met with FDA senior managers (including Commissioner von Eschenbach) in October before FDA decidied to support the Centers for Medicare and Medicaid Services in its effort to restrict use of EPO for chemotherapy patients.
Howard Heinz University Professor
Department of Social and Decision Sciences
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England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
