Submit revised BE study protocol: CDSCO panel tells Laurus Labs on Carglumic Acid Dispersible Tablets
New Delhi: Rejecting drug maker Laurus Lab’s proposal for clinical trial waiver of Carglumic acid dispersible tablets 200mg, the subject committee expert (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit a revised bioequivalence (BE) study protocol by capturing complete details such as the objective of the study, […] More