FDA Adboard on Tedizolid – Why?
FDA’s Advisory Board session for tedizolid (3/31/2014) was a foregone affair: Looking at the reviewer’s slides, there was really no question about the drug’s efficacy. Did tedizolid cure as many patients as linezolid? Yes, it did. Did the sponsor follow the latest ABSSSI Guidance criteria for establishing non-inferiority? Yes, they Continue reading FDA Adboard on Tedizolid – Why?