Home » US FDA Minimizing Noninferiority Trials in Guidance on Developing Direct Antivirals for Hep C
US FDA Minimizing Noninferiority Trials in Guidance on Developing Direct Antivirals for Hep C
September 16, 2010
The U.S. Food and Drug Administration’s (FDA’s) continued emphasis on minimizing noninferiority clinical trials in drug development now urges drugmakers to use superiority trials for initial registration of direct-acting antiviral agents (DAA) for hepatitis C (HCV), according to a new draft guidance.
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