US FDA panel to take on knotty anti-NGF challenge
This article was originally published in Scrip
Executive Summary
The US FDA has been grappling with the knotty challenge of how to regulate an experimental class of drugs, known as anti-nerve growth factors (anti-NGFs), which regulators said "represent a potentially significant and novel strategy for the treatment of pain," but have been linked to osteonecrosis and avascular necrosis (AVN) – all leading to joint replacement – and wants a panel of outside experts to help the agency decide whether to permit drug makers to proceed with clinical testing.