Reform of clinical trials directive must be future-proof

Europe’s attempt to unify rules on clinical trials in the 2001 Directive is widely acknowledged to be a disaster. After years of debate, the Commission’s proposals for reform are getting a favourable reception, but it is critical the new regulation takes account of emerging technologies

New UK rules for medical devices trials

The UK has brought in new rules it says will make it easier to get permissions to carry out clinical trials of medical devices, such as hip and knee replacements, pacemakers and stents.

Wait for the ricochet

The conclusion that there was nothing wrong with the specifics of the TeGenero trial in which six healthy volunteers ended up in intensive care has repercussions for the wider biotech industry.