- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
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...
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
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.