FDA,CMS Build Drug Safety System Prototype
This article was originally published in The Pink Sheet Daily
Coming Medicare final rule enables FDA to access Part D data for public health and safety research.
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Among solutions suggested is six-year fixed term for the FDA commissioner and appointment of external advisory board to oversee cultural changes.
AstraZeneca/FibroGen’s Roxadustat Comparison To ESAs In Anemia May By Clarified At FDA Advisory Cmte.
Payers would welcome any additional clarity provided by advisory panel review, given the perception, expressed in a recent ICER report, that the evidence is insufficient to determine whether the new drug is safer or more effective than erythropoiesis-stimulating agents.
Elizabeth Fowler brings combination of Capitol Hill, White House and pharma industry experience to the role of director of the Center for Medicare and Medicaid Innovation.