Anticancer drug: CDSCO panel seeks data for Eli Lilly Selpercatinib
In response to the drug major Eli Lilly's proposal to waive off Phase IV clinical trial in the country for the Selpercatinib 40 & 80mg capsules, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should submit the criteria of dose justification, comparative safety data for the Indian patients, and the...
In response to the drug major Eli Lilly's proposal to waive off Phase IV clinical trial in the country for the Selpercatinib 40 & 80mg capsules, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should submit the criteria of dose justification, comparative safety data for the Indian patients, and the Global study particularly ICH countries who participated in the study by including all adverse events (AEs) and serious adverse effects (SAEs).
For more details, check out the link given below:
CDSCO Panel Seeks Data For Eli Lilly's Anticancer Drug Selpercatinib
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