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

August 14, 2013 by Arezu Sarvestani

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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"This consolidation initiative provides the opportunity to further develop and coordinate scientific and regulatory activities between CDRH and CBER. FDA believes that as more wound care products containing live cells are developed such consolidation is necessary for both efficient and consistent Agency action," according to the FDA statement.

CBER is tasked with regulating cellular therapy, gene therapy and devices related to those products. The shift took effect immediately today.

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