EMA develops a Concept Paper on the development of guidance concerning use of external controls for evidence generation in regulatory decision making
European Medicines Agency, External Controls Elisabethann Wright European Medicines Agency, External Controls Elisabethann Wright

EMA develops a Concept Paper on the development of guidance concerning use of external controls for evidence generation in regulatory decision making

The European Medicines Agency (EMA) has published a Concept Paper on the Development of a Reflection Paper on the Use of External Controls for Evidence Generation in Regulatory Decision Making (Concept paper).

The Concept Paper recalls the current lack of specific regulatory guidance concerning the use of external controls to support regulatory decision making

Read More