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Monthly Archives: December 2010
A Fine Line Between Regulation and Evolution
The strict regulatory divide between market authorization and price reimbursement is crumbling in the US. Ansis Helmanis asks — is industry prepared to adapt or challenge?
On September 17, the FDA and CMS jointly issued a Federal Register (FR) notice that they were establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when [...]
Posted in FDA, Market Access, Regulatory Tagged FDA, Market Access, market authorization, Regulatory, reimbursement Leave a comment
Ireland's Economic Bailout to Sting Pharma
Ireland’s favorable level of corporation tax remains untouched by the country’s economic rescue package, but drugmakers will still feel the pinch of the healthcare cuts.
Despite pressure from France and Germany, Ireland has managed to secure its Euro 85 billion ($111 billion) rescue package from Europe and the International Monetary Fund without raising corporation tax, one [...]
Posted in Europe, Global, Regulatory Tagged austerity, budgets, Global, healthcvare, Ireland, tax Leave a comment
Pfizer: A Sudden Change at the Helm