FDA's Pediatric Advisory Subcommittee on Pediatric Ethics will meet June 9-10 to discuss clinical investigations that involve greater than minimal risk but present the prospect of direct benefits to individual subjects. The June 9 discussion will be illustrated with hypothetical cases of research involving HIV vaccines in adolescents and controlled trials of inhaled corticosteroids in children with asthma, and the June 10 discussion with a hypothetical case of research using stem cells for treating periventricular white matter injury in children
You may also be interested in...
With a late-stage compound on its hands, MGB is currently in discussions with several biotech and pharma companies and also with venture capitalists to continue late-stage development of a novel antibiotic which could transform treatment of Clostridium difficile.
AZ and the EU are at loggerheads over supplies of the COVID-19 vaccine. On top of that, its marketing authorization will present dilemmas.
The European Medicines Agency is expected to decide soon whether Amarin’s fish oil pill, Vascepa, should win pan-EU marketing approval for reducing cardiovascular risk.