Berlin Heart GmbH

FDA's Pediatric Advisory Committee (PAC) is scheduled to meet for two days in mid-September to discuss a range of products, including four devices with humanitarian device exemptions (HDE) for use in

Five medical devices will be on the agenda Sept. 14 when US FDA's Pediatric Advisory Committee will gather for its latest meeting . The committee is tasked with performing statutorily mandated pedi

The regulatory pathway for nearly every product developed to treat a rare disease begins and ends with FDA's Office of Orphan Product Development. That office reviews requests from sponsors for orphan

The regulatory pathway for nearly every product developed to treat a rare disease begins and ends with the Food & Drug Administration’s Office of Orphan Product Development. That office reviews reques