Update of list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. Accessed December 11,2000. Aggression, conduct disorder could be pediatric drug development targets. FDA Modernization Act of 1997 and related documents. Accessed December 8, 2000.
New rule requires labeling information for pediatric use.
U.S. Department of Health and Human Services, Food and Drug Administration, Centers for Drug Evaluation and Research, Center for Biologics Evaluation and Research. FDA considering partial written requests for pediatric studies. Lamictal product information. The FDA is currently evaluating a plan to change requirements for drug labeling concerning pregnancy and lactation. Health care providers have lobbied for more information on product labeling, reflecting the data available in the medical literature.