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table 6 case report form

Performance evaluation report from a laboratory designated under subrule (1) of rule ...

table 6 case report form

Actions taken in reporting interval for safety reasons: This section of PSUR shall in ...

table 6 case report form

If the application for grant of licence or loan licence to manufacture for sale or fo ...

table 6 case report form

Purpose for which samples have been taken When a Medical Device Officer takes a sampl ...

3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer are required to obtain manufacturing/ import permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before Licencing the product under the Drugs Rules, 1945. 4. Robust system for evaluation of applications of clinical trial and new drug which contains data of Chemistry, Manufacture, Control ...

table 6 case report form

Explanation : For the removal of doubt, it is hereby declared that in case of such IS ...

table 6 case report form

CLINICAL INVESTIGATION (1) Approval for clinical investigation: (i) Clinical investig ...

table 6 case report form

THIRD SCHEDULE [Refer rules 13(5), 13(9), 14, 15, 20(4), 20(6)] DOCUMENTS REQUIRED FO ...