Pediatric Drug Data Scarcity Prompts FDA to Revise Guidance

Revised draft guidance on pediatric clinical trials aims to tackle the lack of adequate information on how well drugs work in kids.

The Food and Drug Administration Wednesday released draft guidance on the general clinical pharmacology considerations for pediatric drug and biologic studies. The latest iteration replaces another draft the agency issued nearly eight years ago.

While there are a number of laws and regulations aimed to encourage pediatric drug development, clinicians are often left without adequate data about how well a drug works in children. A 2018 study found nearly half the medicines clinicians commonly prescribed for ...