Opioid analgesia for acute low back pain and neck pain (the OPAL trial): a randomised placebo-controlled trial thelancet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thelancet.com Daily Mail and Mail on Sunday newspapers.
Institutional review boards and ethics committees have seen it as their main task in the past few decades to protect children from questionable studies; however, they are faced with a new challenge with pediatric drug development.
UCB Provides Update on U.S. FDA Review of the Biologics License Application for Bimekizumab Brussels (Belgium), 26th June 2023 - 18:30 CEST - Regulated Information - Inside Information - UCB, a global biopharmaceutical comp.
Imposing the FDA on-label/off-label framework on administratively defined "children" resulted in a regulatory demand for pediatric studies that had no basis in clinical medicine, with the exception of the small group of preterm newborns.