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Home » Use ‘Mock’ Resistance Datasets for Direct-Acting Hep C Antivirals
Use ‘Mock’ Resistance Datasets for Direct-Acting Hep C Antivirals
February 27, 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, new guidance says.