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Amgen Lead Discussion on Successful Launch Strategy Under New FDAAA Guidelines

Published in Medical Letter on the CDC and FDA, March 22nd, 2009

With FDA guidelines likely to become more stringent under the Obama administration, Pharma oncology companies are meeting to look at how to develop and execute a Risk Evaluation and Mitigation Strategy (REMS).

Led by industry expert, Max Colao, Executive Director, Oncology Marketing, Amgen, the discussion will take the audience through the implications of the new FDAAA guidelines on oncology launch strategy.

Drawing key learnings from, Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding, Max and other leading industry...

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Source: Medical Letter on the CDC and FDA (2009-03-22)

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