PL. 107-109 of the BPCA reauthorizes the pediatric studies provision of the 1997 Modernization Act to improve the safety and efficacy of pharmaceuticals for children. It continues to encourage pharmaceutical companies to conduct studies of on-patent drugs that are used in pediatric populations (but that are not labeled for such use) by extending their market [...]

After several years of clinical studies, important label changes have had an impact on the use of these drugs in children (Table 1).
2002 and 2003
In January 2003, the Secretary of DHHS revealed that 12 commonly prescribed drugs would now require clinical testing for use in children. The governmental agencies (DHHS and FDA) have [...]

1979
The FDA, working under the aegis of the Congress, began to persuade pharmaceutical companies to provide pediatric labeling information on drugs if such data were available. Initially, a 1979 FDA regulation required full clinical trials in pediatric populations as the basis for drug labeling for chil-dren, but progress in achieving this goal was made very [...]

PROBLEMS OF DRUG TESTING IN CHILDREN
Children obviously need medicines, medical health professionals agree, but they are considered “therapeutic orphans” when it comes to drug development. Most drugs are studied, approved, and labeled for use in adults. To use one of these approved drugs for the same disease in children, it is important to know which [...]