Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

CURAGEN INITIATES SECOND VELAFERMIN TRIAL

CuraGen has announced the initiation of patient dosing in a Phase II clinical trial evaluating a single dose of velafermin for the prevention of oral mucositis (OM).

This clinical trial, the second Phase II study of velafermin, is designed to assess the safety and efficacy of velafermin for the prevention of OM in cancer patients receiving high-dose chemotherapy, with or without radiotherapy, in the setting of autologous bone marrow transplantation (BMT).

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CURAGEN INITIATES SECOND VELAFERMIN TRIAL

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