FDA Panel Deems Non-inferiority Trials For J&J’s Doribax Inferior
FDA’s Anti-Infective Drugs Advisory votes 10-3 that a 20 percent non-inferiority margin for the antibiotic is not scientifically justifiable.
FDA’s Anti-Infective Drugs Advisory votes 10-3 that a 20 percent non-inferiority margin for the antibiotic is not scientifically justifiable.