Newborns still lack drug data to guide therapy.

The authors discuss the recognition of the lack of paediatric studies of medications in the U.S. within five years of the 1962 passage of legislation, requiring new drugs to be shown to be both safe and effective for approval. They note the complicated and limited number of studies of relevant drugs in neonates as all paediatric studies are problematic. They also mention the development of a comprehensive white paper describing how to study drugs in neonates.