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Baxter Healthcare Corp.
Baxter collaborates with Gambro BCT on 7-day platelet study to speed adoption
June 23rd, 2006
In an effort to speed adoption of a 7-day platelet protocol, Baxter Healthcare Corp. will join Gambro BCT in supporting the PASSPORT (Post Approval Surveillance Study of Platelet Outcomes, Release Tested) post-market surveillance study. Baxter and Gambro will jointly manage and implement the PASSPORT Study. Baxter will submit the PASSPORT Study plan to the U.S. Food and Drug Administration (FDA) to fulfill its post-market surveillance study requirement. In November 2005, Baxter received FDA clearance for the 7-day storage of platelets collected on the Amicus Separator and stored in Baxter's PL 2410 storage container . This clearance, which was...
Source: Biotech Law Weekly (2006-06-23)
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