10.As provided in the rules, surrogate marker should be considered as an interim data point and further clinical data should be generated following the approval of the new drug based on surrogate marker consideration that must unequivocally support the patients benefit.
11.Upon receipt of NDA the CDSCO should review the application to determine its completeness within timeline to be prescribed wit ...
Accredited Consultants Pvt Ltd 2023-10-28T05:49:20 2023-10-28T05:49:20
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10.As provided in the rules, surrogate marker should be considered as an interim data point and furt