Current Edition

A New Twist in the Brief History of the Cardiac Safety Regulations

An Update of the ICH- E14 and S7B 2000 Q&A Revision

Cardiac toxicity of pharmaceuticals, primarily drug-induced proarrhythmia and the risk of sudden cardiac death, emerged
as a primary public and regulatory drug safety concern. Boaz Mendzelevski at Cardiac Safety Consultants Ltd looks at new guidance designed to establish an infallible scientific and regulatory process to ensure the cardiac safety of new drugs in development.