Sanofi gets CDSCO Panel nod to study Amlitelimab
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-10-31 12:00 GMT | Update On 2024-10-31 12:00 GMT
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New Delhi: The drug major Sanofi has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a phase III clinical study of Amlitelimab.
However, this approval is subject to the requirement that the firm submit a separate detailed protocol and procedure to ensure standardized monitoring across all the study sites, specifically a detailed document informing investigators about screening for cutaneous/extracutaneous lymphoma steps of diagnosis and reporting to CDSCO.
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