What Is a Registrational Trial?

Registrational Trial means a controlled or uncontrolled human Clinical Trial of a Licensed Product that is intended (as of the time the first patient is enrolled in the Clinical Trial) to obtain sufficient data and results to support the filing of an application for Regulatory Approval without the requirement for any ...

What defines a pivotal trial?

What is a pivotal clinical trial? A pivotal clinical trial is a clinical study seeking to demonstrate the efficacy of a new drug in order to obtain its marketing approval by regulatory authorities (e.g. FDA in the United States and EMA in Europe).

What is a non registrational clinical trial?

Non-Registrational Trial means a Clinical Trial for a particular indication that (a) is initiated or ongoing after completion of the first Phase III Trial for such indication, and (b) is not conducted to obtain, maintain or expand Regulatory Approval of the Product being tested.