Pivotal Clinical Investigation: (i) The pivotal clinical investigation is a definitiv ...

If the application is for conduct of clinical investigation as a part of multi-nation ...

(ii) Detailed information: Detailed information should include: (a) complete study pr ...

16.0 Claimed Shelf life: This section should provide information on stability testing ...

14.0 Definition of Assay Cut-off: This section should provide a summary of analytical ...

16.0 Claimed Shelf life: This section should provide information on stability testing ...

18.0 Shipping stability: This section should provide information on shipping stabilit ...

10.0 Analytical sensitivity: This section should include information about the study ...