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Home » FDA Seeks ‘Mock’ Resistance Datasets for Direct-Acting Hep C Antivirals
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FDA Seeks ‘Mock’ Resistance Datasets for Direct-Acting Hep C Antivirals
March 1, 2013
Sponsors of clinical trials for direct-acting hepatitis C antivirals are encouraged to submit preliminary or “mock” virology and drug resistance datasets to the FDA’s Division of Antiviral Products before assembling their formal resistance datasets, a new guidance attachment says.