Cell and Gene Therapy

Regulatory and Ethical Issues of Therapies

The U.S. Food and Drug Administration's (FDA's) new Paediatric Rule makes it more likely that children will receive improved treatment, because physicians will have more complete information on how drugs affect children and the suitable  doses for each age group (FDA, 1998e). The rule also allows FDA to require industry to test already marketed products in studies with paediatric populations in certain fascinating circumstances, such as when a drug is commonly prescribed for use in children but when the absence of adequate testing and labelling could be significant risks. The aim of this session is to examine many interrelated legal and regulatory issues, as well as the interrelated social and ethical concerns, in the evaluation of the effects of drugs and biologics on paediatric populations.