Innovation in Pediatric Drugs Act of 2025

This bill modifies requirements for pediatric drug studies, particularly for drugs treating rare diseases (orphan drugs). It requires the FDA to issue a noncompliance letter and allow 45 days for response before imposing penalties, and creates an automatic FDA waiver list for diseases where pediatric studies are impractical. Drug sponsors developing orphan drugs for rare conditions will benefit from clearer pathways, as the bill specifies when pediatric studies aren't required unless they offer meaningful therapeutic benefit. The FDA must also report on penalties for noncompliance and update its waiver lists, aiming to streamline development while improving pediatric data for rare diseases.