Thank you for your interest in the FDA Division of Pediatrics and Maternal Health Research Initiative. Research questions that are submitted will appear on this page and be considered by the FDA.
There are no FDA approved vaccine for Childhood Acute Myeloid Leukaemia . Globally, many children are undergoing treatment for this disease which can be cured using vaccine as per recent av
Older population 12-17 - had myocarditis, i read an article about this and the conclusion was - this issue was related to dosing. Will this be studied in the 2-12 population. What is done to prevent this ? Will it be only one dose ?
Flavouring and sweetening are often required to enhance the palatability/acceptability of paediatric products that are intended for delivery as oral liquid dosage forms. What flavours and sweeteners have been used in applications for products that were accepted by the agency and what evidence was provided on the acceptability of those products to the paediatric patients?
How to best scale from adults to pediatrics for compounds displaying target-mediated drug disposition? There are little published information, and the proposed method in literature is vague and requires sensitivity analysis. I hope FDA could review historic data and recommend the best strategy.
It is well know that obesity leads to many chronic diseases. We also know that genetic, behavioral and environmental factors contribute to this continuously growing disease. However, there is insufficient investigation into if pharmaceutical intervention in children could stop and reverse obesity in children, and in turn prevent long term chronic diseases.
Decentralized clinical trials can improve trial homogeneity as well as participant diversity, eliminate geographic barriers, allow for participation in clinical trials through local practices, allow for local subsequent testing, and eliminate participant... more »
For children under 12 who are COVID-19 positive (+), what medical therapeutics treatments have shown most efficacy against COVID-19 which prevented or reduced hospitalization?
Hopefully this can be done by MIDD (meta-analysis) from hospitals, urgent care, and doctor's office who submitted protocol treatments used by the various facilities.
Our preliminary research has found out that targeting TGF-beta and IL-2... more »
Is this therapy associated with systemic toxicities including worsened bronchopulmonary dysplasia,... more »
Would be there any biomarker like C-reactive protein which predicts long-term efficacy in pediatric patients with Crohn's disease and ulcerative colitis.