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ATS seeking FDA advisory opinion on Dermagraft-TC regulation by New York state.

This article was originally published in The Gray Sheet

Executive Summary

ATS AWAITING FDA OPINION ON DERMAGRAFT-TC PMA's PRE-EMPTION of New York's human tissue regulations. Advanced Tissue Sciences sought the opinion in response to the New York State Department of Health's attempt to subject the temporary skin replacement product to state tissue bank licensing requirements.

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