PRESENTATION AND SUBMISSION OF APPLICATION 1. In order to make regulatory review process as efficient for CDSCO as possible, the submission of applications for approval of clinical trials and new drugs to CDSCO ensuring conciseness, correctness, consistency and clarity. 2. A clear well-presented submission facilitates the evaluation process in a timely manner, whereas, a difficult-to-evaluation su ...

ND & CT rules recognize the consideration of surrogate endpoints for approval of new drugs in certain situation where, the approval of a new drug may be based on the clinical data generated considering surrogate end-point rather than using standard outcome measures such as survival or disease progression which are reasonably likely to predict clinical benefit, or a clinical end point. 8. Surrogate ...