Affiliation: Food and Drug Administration
- Drug therapy in pediatrics: a developing fieldLisa Mathis
Office of New Drugs, FDA, Silver Spring, Maryland 20903, USA
Dermatol Ther 22:257-61. 2009..With the new legislation and a better understanding of differences in the dose effectiveness and safety profiles of drugs in children when compared with adults, evidence-based treatment of pediatric patients is now possible...
- Safety monitoring of drugs granted exclusivity under the Best Pharmaceuticals for Children Act: what the FDA has learnedL L Mathis
Office of New Drugs, US Public Health Service, Silver Spring, Maryland, USA
Clin Pharmacol Ther 82:133-4. 2007..In most of the cases, no unexpected adverse events were reported in the pediatric population; however, in some cases, this focused safety review provided information important to the safety of medication use in children...
- Improving pediatric dosing through pediatric initiatives: what we have learnedWilliam Rodriguez
Food and Drug Administration, 5600 Fisher Lane, Parklawn Building, Room 13B 45, Rockville, MD 20850, USA
Pediatrics 121:530-9. 2008..The goal was to review the impact of pediatric drug studies, as measured by the improvement in pediatric dosing and other pertinent information captured in the drug labeling...