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FDA transfers stem cell wound care review away from medical device arm

Wed, 08/14/2013 - 12:11pm
Mass Device

Effective immediately, the FDA transfers review of certain live-cell wound care therapies from the Center for Devices & Radiological Health to the Center for Biologics Evaluation & Research.

FDA transfers certain wound care review responsiblities within agency

The FDA is shifting some of its wound care review responsibilities away from the Center for Devices & Radiological Health, handing them instead to the Center for Biologics Evaluation & Research.

Some of the products transfered include the Apligraf diabetic foot and venous leg ulcer treatment from Organogenesis and the Dermagraft venous leg ulcer skin substitute by Shire (NSDQ:SHPGY) subsidiary Advanced BioHealing, according to a notice in the Federal Register.

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