CDSCO panel seeks data for Eli Lilly's anticancer drug selpercatinib
New Delhi: 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).
In addition, the expert panel suggested the firm submit information regarding the reason why, out of 41 screened patients, only 07 were randomised and 32 were discontinued before randomization.
This came after the firm presented its proposal to waive off Phase IV clinical trial in the country, before the committee.
Also Read:Zydus Healthcare gets CDSCO panel nod to study Dydrogesterone film coated Sustained Release Tablets
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.