Snapshot » Fragmin http://www.raymondstevenson.com Expert and creative communications services for the pharmaceutical and biotechnology industries. Mon, 06 Feb 2012 12:51:55 +0000 en hourly 1 http://wordpress.org/?v=3.3.1 Product Expertise http://www.raymondstevenson.com/case-studies/product-expertise/ http://www.raymondstevenson.com/case-studies/product-expertise/#comments Thu, 01 Oct 2009 17:38:19 +0000 theadmin http://www.raymondstevenson.com/?p=893 Fragmin fda

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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