Diclofenac regulatory update

EMA's Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) endorsed a recommendation from EMA's Pharmacovigilance Risk Assessment Committee (PRAC) that pain and inflammation drug diclofenac receive the same precautions in effect to minimize the risks of arterial thromboembolic events with selective cyclooxygenase-2 (COX-2) inhibitors. The CMDh position will now be sent to the European Commission, which will take a legally binding decision throughout the EU (see BioCentury, June 24). ...