President of AIFA's Techincal-Scientific Commitee
Anatomy of the approval of a drug: safety, effectiveness and costs
The approval of a drug may require from 9 to 16 years after the identification of the active substance that is considered of potential therapeutic interest. The relevant cost ranges from $ 900 million to $ 1.8 billion, on average. The longest and most expensive steps of developing a drug are basic research and clinical trials. Why are costs so high? How will technological innovations change timing and costs for approving new drugs? How do requests to reduce or modulate in a different way the mark-up by regulatory agencies make sense?
Event by Alfasigma.