Engaging early with regulators and Health Technology Assessment (HTA) bodies gives the opportunity to get input on key aspects of drug development. This is however far from the only reason companies have for seeking advice before starting their pivotal clinical trials.
At NDA we’ve worked with hundreds of companies over the years, provisioning specific scientific advice ourselves, or preparing development teams for critical interactions with the agencies. Over this time, we’ve seen a diverse range of reasons for embarking on this process. In this white paper, written by Dr. Mira Pavlovic-Ganascia HTA expert NDA Group and Claes Buxfeldt HTA Director NDA Group, we will look more closely at some of these reasons, provide a short overview on the current state of the system and elaborate on what the expected outcomes of constructively engaging with regulators and HTA bodies could be.