Risk-benefit decisions in product licence applications

Abstract

The papers presented have demonstrated that the licensing of a drug is a permanent process. Although the granting of a licence – or not – is a very important time in the life of a drug, risk–benefit decisions are also made before and after this event. They are made early on in the development by the pharmaceutical manufacturer, then at the Investigational New Drug (IND) and New Drug Application (NDA) stage by the pharmaceutical manufacturer and the regulatory agency concerned, the later on also by the physician. Whenever new data are available, an update of the risk-benefit decision is required. The evaluation carried out can change the balance from good to bad or vice versa.