ADR reporting: conflicts within and between countries
Adverse drug reaction (ADR) reporting is not a simple matter. It becomes even less so when conflicting regulations and guidelines are issued in the same country. This is the current state of play in the US, according to Dr Barton Cobert, senior director of medical and safety services at Schering-Plough Research Institute, US. Dr Cobert provided a critical appraisal of the regulatory scenario that has been set up by the US FDA. He also described the similarities and differences in harmonisation efforts in the US, Japan and Europe. Dr Cobert presented his views at the IIR Ltd meeting on ‘Collecting, Managing and Presenting ADR Information’ [ London, UK; February 1996 ].