Posted by Michael Wonder on 16 Jun 2020
Advancing structured decision‐making in drug regulation at the FDA and EMA
11 June 2020 - FDA’s recent benefit‐risk framework was developed for improving the clarity and consistency in communicating the reasoning behind its decisions, acting as an important advancement in US drug regulation.
In the PDUFA VI implementation plan, FDA states that it will continue to explore more structured or quantitative decision analysis approaches, however it restricts their use within the current BRF that is purely qualitative.
By contrast, European regulators and researchers have been long exploring the use of quantitative decision analysis approaches for evaluating drug benefit‐risk balance.
