Product Expertise

By Betsy Raymond Stevenson, posted October 1, 2009

Context:

• FDA Cardiology Advisory Committee to review blood-thinner Fragmin for quality of life indication in terminal cancer patients

Challenge:

• Higher mortality rates in Fragmin study arm viewed negatively by FDA

Solution:

• Advised Pfizer team how to clarify the misunderstanding and revised the proposal flow

Results:

• Unanimous approvable recommendation by the FDA Committee for the new indication

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