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Article: FDA Issues Guidance for Derma Sciences' Exclusive Wound Dressing With pDADMAC.
- Article from:
- Biotech Week
- Article date:
- November 11, 2009
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Derma Sciences, Inc. (BULLETIN BOARD: DSCI) , a specialty medical device / pharmaceutical company specializing in advanced wound care, announced that the Food and Drug Administration has issued its Guidance Document to support the classification of the Company's BIOGUARD™ barrier gauze wound dressings as Class II medical devices. This novel wound dressing received its initial market clearance on February 25, 2009, via the FDA's De Novo review process, a special clearance program for medical devices that are found to be "not substantially equivalent" to any predicate device (see also Drug Resistance).
Commenting on the move by the FDA, Derma Sciences CEO ...
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Article: Derma Sciences Reports Results for Third Quarter ...
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... ... PRINCETON, N.J. -- Derma Sciences, Inc. (OTCBB ... President and CEO of Derma Sciences commented, "We believe ... Active Manuka Honey Wound Dressing and we are anticipating ... looks promising for Derma Sciences." Derma Sciences ...
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