UNDERTAKING BY THE INVESTIGATOR 1. Full name, address and title of the Principal Investigator (or Investigator(s) when there is no Principal Investigator). 2. Name and address of the medical college, hospital or other facility where the Clinical Investigation will be conducted: Education, training & experience that qualify the Investigator for the clinical investigation Central Drugs Standard ...

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 ...