Context: Off-label and unlicensed use of drugs is a widespread practice in pediatric care because of the lack of specific efficacy and safety data and the absence of formulations adapted to the needs of these individuals. Pediatric patients with a…
BACKGROUND: The management of pain in children has advanced enormously in recent years. Pharmacological treatment of pain is complicated however, by the widespread use of unlicensed and off label medicines in the paediatric population, leading to…
New regulatory initiatives have been designed to ensure that new drugs and biologicals include adequate pediatric labeling for the claimed indications at the time of, or soon after, approval. However, because such labeling may not immediately be…
