Can FDA require a sponsor to conduct pediatric studies if the disease only occurs in certain pediatric subpopulations?
A26. Yes. FDA can require a sponsor to conduct pediatric studies even if only a small number of children are affected if the information would provide a meaningful therapeutic benefit in pediatric patients. FDA should issue a partial waiver for the age groups in which the disease does not occur. In addition, if the sponsor tries to conduct a study in the affected population but cannot complete the study, perhaps due to a very small number of patients in which the disease occurs, FDA may issue a waiver.
Related Questions
- Can FDA require a sponsor to conduct pediatric studies if the disease only occurs in certain pediatric subpopulations?
- Can FDA require a sponsor to conduct preclinical (animal pharmacology/toxicology) studies in young animals?
- Does a sponsor HAVE to conduct pediatric studies if it receives a Written Request from FDA?
