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 ...

We have a young professional team working on regulatory submissions for pharmaceutical products and other client-specific projects. We pride ourselves in having first-hand knowledge of drug regulatory rules etc. and keep ourselves updated all the time.