Drug regulatory agencies face the challenge of striking the appropriate balance between the need for rapid access to new drugs and the need to obtain comprehensive data on their benefit/risk profiles. This article highlights the scientific and regulatory issues involved, discusses regulatory strategies to address these issues, and speculates on future directions, such as a life-cycle approach to drug regulation.
- Hans-Georg Eichler
- Francesco Pignatti
- Alasdair Breckenridge
