Government Reform Committee members discuss extending their investigation on Vioxx promotional practices to other COX-2 drugs. FDA Office of New Drugs' Jenkins rebukes Merck for avoiding discussion of certain cardiovascular risk data during physician detailing visits before a 2002 Vioxx labeling change.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.
The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.
