Insufficient Efficacy, Safety Data: CDSCO Panel Rejects Zydus’ Phase III CT Waiver Request for Voclosporin
New Delhi: Citing lack of sufficient efficacy and safety data to prove that the dose requirement in the Indian population is adequate, the Subject Expert Committee (SEC), functioning under the Central Drug Standard Control Organisation (CDSCO), has rejected Zydus Lifesciences’ proposal to conduct a phase III clinical trial of Voclosporin capsule 7.9 mg. This came […]